- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00650767
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Hospital Británico
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Buenos Aires, Argentina
- Cemic
-
Buenos Aires, Argentina
- Asistencia Integral en Reumatologia
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San Juan, Argentina
- CER San Juan
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San Miguel de Tucumán, Argentina
- Centro Medico Privado de Reumatologia
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Santa Fe, Argentina
- Centro de Investigaciones Clinicas del Litoral SRL
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-
-
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GO
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Goiânia, GO, Brazil, 74110-120
- Médicos Unidos Ltda.
-
-
PR
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Curitiba, PR, Brazil, 80060
- CETI - Hospital das Clínicas da Universidade Federal do Paraná
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RS
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Porto Alegre, RS, Brazil, 90035-003
- Hospital de Clínicas de Porto Alegre
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Porto Alegre, RS, Brazil, 90610-000
- Hospital São Lucas da da Pontifícia Universidade Católica do Rio Grande do Sul
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SP
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São Paulo, SP, Brazil, 04230-000
- Hospital Heliópolis
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São Paulo, SP, Brazil, 04026-000
- Hospital São Paulo / Instituto Paulista de Reumatologia
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São Paulo, SP, Brazil, 05437-010
- Instituto de Medicina Avancada (IMA Brasil)
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Budapest, Hungary
- Budai Irgalmasrendi Kórház - Allergólógia és Immunológia
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Budapest, Hungary
- Synexus Ltd Hungary
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Gyula, Hungary
- Békés Megyei Pándy Kálmán Kórház - Rheumatology
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Mezőkövesd, Hungary
- Mozgasszervi Rehabilitacios Kozpont
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Szolnok, Hungary
- MÁV Kórház - Clinical Pharmacology
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Szombathely, Hungary
- Vas Megyei Markusovszky Korhaz Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház, Zártkörűen Működő Nonprofit Részvénytársaság - Rheumatology
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Székesfehérvár, Hungary
- Fejér Megyei Szent György Kórház - Rheumatology
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Arequipa, Peru
- Instituto de Investigacion y Seguridad Medica EIRL
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Lima, Peru
- Clinica San Felipe - Centro de Estudios Clinicos CGYM
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Lima, Peru
- Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia
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Lima, Peru
- Hospital Maria Auxiliadora - Centro de Investigaciones Medicas
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Bialystok, Poland
- Centrum Osteoporozy i Chorób Kostno-Stawowych
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Elblag, Poland
- Wojewódzki Szpital Zespolony - Oddział Reumatologiczny
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Gdynia, Poland
- Centrum Leczenia Chorob Cywilizacyjnych
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Lublin, Poland
- NZOZ Reumed
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Warszawa, Poland
- Centrum Leczenia Chorob Cywilizacyjnych
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Wroclaw, Poland
- Synexus SCM Sp. z o.o.
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Bucuresti, Romania
- Spitalul Clinic "Sf, Maria"
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Cluj-Napoca, Romania
- Spitalul Clinic Județean de Urgență
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Targu Mures, Romania
- Spitalul Clinic Județean de Urgență
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Timisoara, Romania
- Cabinet Medical "Prof. Dr. Miorara Banciu"
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South Carolina
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Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
- Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
- Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
- No prior use of biological agents for the treatment of rheumatoid arthritis.
- Additional criteria exist.
Key Exclusion Criteria:
- Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
- A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
- Additional criteria exist.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
matching placebo
|
Experimental: ARRY-438162 (Schedule 1)
|
multiple dose, single schedule
|
Experimental: ARRY-438162 (Schedule 2)
|
multiple dose, single schedule
|
Experimental: ARRY-438162 (Schedule 3)
|
multiple dose, single schedule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
American College of Rheumatology 20% (ACR20) Response Rate at Week 12
Time Frame: Week 12
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
American College of Rheumatology 20% (ACR20) Response Rate at Week 1
Time Frame: Week 1
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 1
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 2
Time Frame: Week 2
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 2
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 4
Time Frame: Week 4
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 4
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 8
Time Frame: Week 8
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 8
|
American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)
Time Frame: Week 16 (Follow-up)
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria. |
Week 16 (Follow-up)
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 1
Time Frame: Week 1
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 1
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 2
Time Frame: Week 2
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 2
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 4
Time Frame: Week 4
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 4
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 8
Time Frame: Week 8
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 8
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 12
Time Frame: Week 12
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 12
|
American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)
Time Frame: Week 16 (Follow-up)
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria. |
Week 16 (Follow-up)
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 1
Time Frame: Week 1
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 1
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 2
Time Frame: Week 2
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 2
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 4
Time Frame: Week 4
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 4
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 8
Time Frame: Week 8
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 8
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 12
Time Frame: Week 12
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 12
|
American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)
Time Frame: Week 16 (Follow-up)
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria. |
Week 16 (Follow-up)
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time Frame: Baseline
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Baseline
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time Frame: Week 1
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 1
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time Frame: Week 2
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 2
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time Frame: Week 4
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 4
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time Frame: Week 8
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 8
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time Frame: Week 12
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 12
|
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time Frame: Week 16 (Follow-up)
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness. |
Week 16 (Follow-up)
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time Frame: Baseline
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Baseline
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time Frame: Week 1
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 1
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time Frame: Week 2
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 2
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time Frame: Week 4
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 4
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time Frame: Week 8
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 8
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time Frame: Week 12
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 12
|
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time Frame: Week 16 (Follow-up)
|
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling. |
Week 16 (Follow-up)
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time Frame: Baseline
|
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
|
Baseline
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time Frame: Week 1
|
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
|
Week 1
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time Frame: Week 2
|
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
|
Week 2
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time Frame: Week 4
|
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
|
Week 4
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time Frame: Week 8
|
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
|
Week 8
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time Frame: Week 12
|
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
|
Week 12
|
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time Frame: Week 16 (Follow-up)
|
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
|
Week 16 (Follow-up)
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Baseline
|
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Baseline
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 1
|
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 1
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 2
|
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 2
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 4
|
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 4
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 8
|
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 8
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 12
|
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 12
|
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 16 (Follow-up)
|
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly). |
Week 16 (Follow-up)
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Baseline
|
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Baseline
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 1
|
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 1
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 2
|
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 2
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 4
|
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 4
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 8
|
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 8
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 12
|
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 12
|
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time Frame: Week 16 (Follow-up)
|
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad). |
Week 16 (Follow-up)
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Baseline
|
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Baseline
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Week 1
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The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 1
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Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Week 2
|
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 2
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Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Week 4
|
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 4
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Week 8
|
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 8
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Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Week 12
|
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 12
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Week 16 (Follow-up)
|
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. |
Week 16 (Follow-up)
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C-Reactive Protein (CRP) at Baseline
Time Frame: Baseline
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Baseline
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C-Reactive Protein (CRP) at Week 1
Time Frame: Week 1
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Week 1
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C-Reactive Protein (CRP) at Week 2
Time Frame: Week 2
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Week 2
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C-Reactive Protein (CRP) at Week 4
Time Frame: Week 4
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Week 4
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C-Reactive Protein (CRP) at Week 8
Time Frame: Week 8
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Week 8
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C-Reactive Protein (CRP) at Week 12
Time Frame: Week 12
|
Week 12
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C-Reactive Protein (CRP) at Week 16 (Follow-up)
Time Frame: Week 16 (Follow-up)
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Week 16 (Follow-up)
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Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Time Frame: Baseline
|
The DAS28-4(CRP) score is a measure of the subject's disease activity.
DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP.
DAS28 provides a number on a scale (0 to 10) indicating current disease activity.
A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
|
Baseline
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Time Frame: Week 1
|
The DAS28-4(CRP) score is a measure of the subject's disease activity.
DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP.
DAS28 provides a number on a scale (0 to 10) indicating current disease activity.
A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
|
Week 1
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Time Frame: Week 2
|
The DAS28-4(CRP) score is a measure of the subject's disease activity.
DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP.
DAS28 provides a number on a scale (0 to 10) indicating current disease activity.
A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
|
Week 2
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Time Frame: Week 4
|
The DAS28-4(CRP) score is a measure of the subject's disease activity.
DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP.
DAS28 provides a number on a scale (0 to 10) indicating current disease activity.
A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
|
Week 4
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Time Frame: Week 8
|
The DAS28-4(CRP) score is a measure of the subject's disease activity.
DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP.
DAS28 provides a number on a scale (0 to 10) indicating current disease activity.
A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
|
Week 8
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Time Frame: Week 12
|
The DAS28-4(CRP) score is a measure of the subject's disease activity.
DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP.
DAS28 provides a number on a scale (0 to 10) indicating current disease activity.
A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
|
Week 12
|
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Time Frame: Week 16 (Follow-up)
|
The DAS28-4(CRP) score is a measure of the subject's disease activity.
DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP.
DAS28 provides a number on a scale (0 to 10) indicating current disease activity.
A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
|
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. |
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
Time Frame: Baseline
|
SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales.
The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health.
Participants self-report on items in a subscale that have choices per item.
Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).
|
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Week 16 (Follow-up)
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
Time Frame: Baseline
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Baseline
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
Time Frame: Week 4
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Week 4
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
Time Frame: Week 8
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Week 8
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
Time Frame: Week 12
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Week 12
|
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
Time Frame: Week 16 (Follow-up)
|
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability, while the higher the score the less disability.
Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
|
Week 16 (Follow-up)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARRAY-162-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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