- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT00661661
Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan
2015. április 23. frissítette: Pfizer
A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis.
Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.
A tanulmány áttekintése
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
487
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
-
Chiba, Japán, 260-8712
- National Hospital Organization Chiba-East Hospital
-
Fukuoka, Japán, 810-8563
- National Hospital Organization Kyushu Medical Center
-
Fukuoka, Japán, 810-0001
- Kondo clinic for rheumatism and orthopaedics
-
Fukuoka, Japán, 812-0025
- Medical Co.LTA PS Clinic
-
Fukusima, Japán, 960-8251
- Fukusima Daiichi Hospital
-
Hiroshima, Japán, 730-0017
- Hiroshima Rheumatology Clinic
-
Kumamoto, Japán, 862-0976
- Kumamoto Orthopaedic Hospital
-
Kyoto, Japán, 602-8566
- University Hospital, Kyoto Prefectural University of Medicine
-
Kyoto, Japán, 606-8507
- Kyoto University Hospital
-
Miyagi, Japán, 982-0032
- Sendai Taihaku Hospital
-
Nagasaki, Japán, 852-8501
- Nagasaki University Hospital of Medicine and Dentistry
-
Niigata, Japán, 951-8520
- Niigata University Medical & Dental Hospital
-
Oita, Japán, 870-0823
- A Medical Corporation Oribe Rheumatism Internist Clinic
-
Osaka, Japán, 530-8480
- The Tazuke Kofukai Medical Research Institute Kitano Hospital
-
Saitama, Japán, 336-8522
- Saitama City Hospital
-
Shinjuku-ku, Tokyo, Japán, 160-8582
- Keio University Hospital
-
-
Aichi
-
Nagoya, Aichi, Japán, 466-8560
- Nagoya University Hospital
-
Nagoya, Aichi, Japán, 460-0001
- National Hospital Organization Nagoya Medical Center
-
-
Chiba
-
Narashino, Chiba, Japán, 275-8580
- Chiba-ken Saiseikai Narashino Hospital
-
Yotukaidou, Chiba, Japán, 284-0003
- Shimoshizu National Hospital
-
-
Fukuoka
-
Iiduka, Fukuoka, Japán, 820-8505
- Aso Iizuka Hospital
-
Kitakyusyu, Fukuoka, Japán, 807-8555
- University of Occupational and Environmental Health Hospital
-
Kurume, Fukuoka, Japán, 830-8543
- St. Mary's Hospital
-
Sawara-ku, Fukuoka, Japán, 814-0002
- SHONO Rheumatism Clinic
-
-
Gunma
-
Takasaki, Gunma, Japán, 370-0053
- Inoue Hospital
-
-
Hiroshima
-
Higashihiroshima, Hiroshima, Japán, 739-0002
- Higashihiroshima Memorial Hospital
-
Hiroshima-city, Hiroshima, Japán, 730-8619
- Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
-
-
Hokkaido
-
Asahikawa, Hokkaido, Japán, 078-8243
- Katayama Orthopedic Rheumatology Clinic
-
Sapporo, Hokkaido, Japán, 060-8648
- Hokkaido University Hospital
-
Sapporo, Hokkaido, Japán, 060-8604
- Sapporo City General Hospital
-
Sapporo, Hokkaido, Japán, 063-0811
- Hokkaido Medical Center for Rheumatic Diseases
-
-
Hyogo
-
Nishinomiya, Hyogo, Japán, 663-8501
- The Hospital of Hyogo College of Medicine
-
-
Ibaraki
-
Hitachi-shi, Ibaraki, Japán, 316-0035
- Taga General Hospital
-
Tsukuba, Ibaraki, Japán, 305-8576
- Tsukuba University Hospital
-
-
Kanagawa
-
Sagamihara, Kanagawa, Japán, 252-0392
- National Hospital Organization Sagamihara National Hospital
-
-
Kumamoto
-
Koushi, Kumamoto, Japán, 861-1196
- Kumamoto Saishunso National Hospital
-
-
Mie
-
Tsu, Mie, Japán, 514-1101
- National hospital Organization Mie Chuou Medical Center
-
-
Miyagi
-
Sendai, Miyagi, Japán, 983-0833
- Hikarigaoka Spellman Hospital
-
-
Nagasaki
-
Ohmura, Nagasaki, Japán, 856-0835
- National Hospital Organization Nagasaki Medical Center
-
Sasebo, Nagasaki, Japán, 857-1195
- Sasebo Chuo Hospital
-
-
Nara
-
Kashihara, Nara, Japán, 634-0007
- Higami hospital
-
-
Osaka
-
Kawachinagano, Osaka, Japán, 586-8521
- National Hospital Organization Osaka Minami Center
-
-
Saga
-
Ureshino, Saga, Japán, 843-0393
- Ureshino Medical Center
-
-
Saitama
-
Kawagoe-shi, Saitama, Japán, 350-8550
- Saitama Medical Center
-
Kitamoto, Saitama, Japán, 364-8501
- Kitasato University Kitasato Institute Medical Center Hospital
-
-
Shizuoka
-
Hamamatsu, Shizuoka, Japán, 430-8558
- Seirei Hamamatsu General Hospital
-
-
Tokyo
-
Arakawa-ku, Tokyo, Japán, 116-8567
- Tokyo Women's Medical University Medical Center East
-
Bunkyo-ku, Tokyo, Japán, 113-8431
- Juntendo University Hospital
-
Bunkyo-ku, Tokyo, Japán, 113-8519
- Tokyo Medical And Dental University Hospital, Faculty of Medicine
-
Bunkyo-ku, Tokyo, Japán, 113-8655
- The University of Tokyo Hospital
-
Chiyoda-ku, Tokyo, Japán, 101-0062
- Sasaki Foundation Kyoundo Hospital
-
Koto-ku, Tokyo, Japán, 136-0075
- Juntendo Tokyo Koto Geriatric Medical Center
-
Meguro-ku, Tokyo, Japán, 152-8902
- National Hospital Organization Tokyo Medical Center
-
Musashimurayama-shi, Tokyo, Japán, 208-0011
- National Hospital Organization Murayama Medical Center
-
Setagaya-ku, Tokyo, Japán, 155-0031
- Fukuhara Hospital
-
Shinjyuku-ku, Tokyo, Japán, 162-0054
- Tokyo Women's Medical University, Institute of Rheumatology
-
-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
20 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis
Exclusion Criteria:
- Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: CP-690 550
|
5 mg BID up to 10 mg BID until launch
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Időkeret: Baseline up to Week 288
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.
|
Baseline up to Week 288
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Időkeret: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Időkeret: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Időkeret: Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Időkeret: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week.
Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do.
Overall score was computed as sum of domain sc ores and divided by number of domains answered.
Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Időkeret: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity).
Total score range:0 to 9.4, higher score indicated more disease activity.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Időkeret: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L).
Total score range: 0 to 9.4, higher score indicated more disease activity.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in Patient Global Assessment of Arthritis
Időkeret: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?"
Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in Physician Global Assessment of Arthritis
Időkeret: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in Patient Assessment of Arthritis Pain
Időkeret: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in Tender/Painful Joint Counts
Időkeret: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
This was carried out on 68 joints.
Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints).
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in Swollen Joint Counts
Időkeret: Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints).
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental
Időkeret: Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
|
Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
|
Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)
Időkeret: First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96
|
mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot).
mTSS scores range from 0 (normal) to 448 (worst possible total score).
Change: scores at observation minus score at baseline.
An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement.
Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study.
|
First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
- Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
- van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.
- Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
- Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
- Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
- Fleischmann R, Wollenhaupt J, Takiya L, Maniccia A, Kwok K, Wang L, van Vollenhoven RF. Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies. RMD Open. 2017 Dec 18;3(2):e000491. doi: 10.1136/rmdopen-2017-000491. eCollection 2017.
- Fleischmann R, Wollenhaupt J, Cohen S, Wang L, Fan H, Bandi V, Andrews J, Takiya L, Bananis E, Weinblatt ME. Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis. Rheumatol Ther. 2018 Jun;5(1):203-214. doi: 10.1007/s40744-018-0093-7. Epub 2018 Feb 7.
- Yamanaka H, Tanaka Y, Takeuchi T, Sugiyama N, Yuasa H, Toyoizumi S, Morishima Y, Hirose T, Zwillich S. Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study. Arthritis Res Ther. 2016 Jan 28;18:34. doi: 10.1186/s13075-016-0932-2.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2008. április 1.
Elsődleges befejezés (Tényleges)
2013. december 1.
A tanulmány befejezése (Tényleges)
2013. december 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2008. február 7.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2008. április 15.
Első közzététel (Becslés)
2008. április 18.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2015. május 12.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2015. április 23.
Utolsó ellenőrzés
2015. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- A3921041
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Rheumatoid arthritis
-
Chang Gung Memorial HospitalMég nincs toborzásArthritis térd | Arthritis csípőTajvan
-
Zimmer BiometToborzásRheumatoid arthritis | Osteo Arthritis térdJapán
-
The University of Hong KongBefejezveOsteo Arthritis térd | Térd rheumatoid arthritis
-
Smith & Nephew, Inc.MegszűntRheumatoid arthritis | Traumás ízületi gyulladás | Osteo Arthritis vállakEgyesült Államok
-
NHS LothianMég nincs toborzásOsteo Arthritis térd | Térd artropátia | Arthritis térdEgyesült Királyság
-
Janssen Research & Development, LLCVisszavontAktív rheumatoid arthritis; Rheumatoid arthritis
-
University of PaviaMég nincs toborzásOsteo Arthritis térd és csípő | Alsó végtagi arthroplasztikaOlaszország
-
Aberystwyth UniversityWelsh Government; Phytoquest Ltd; Gateway Health Alliances, IncToborzásOsteo-arthritisEgyesült Királyság
-
Washington University School of MedicineZimmer BiometBefejezveOsteo Arthritis vállakEgyesült Államok
-
Zimmer BiometBefejezveRheumatoid arthritis | Osteoarthritis ArthritisKoreai Köztársaság
Klinikai vizsgálatok a CP-690,550
-
PfizerBefejezve
-
PfizerBefejezvePikkelysömörEgyesült Államok, Kanada, Németország, Colombia, Magyarország, Japán, Mexikó, Lengyelország, Szerbia, Tajvan, Ukrajna
-
PfizerBefejezvePikkelysömörEgyesült Államok, Kanada, Lengyelország, Szerbia, Németország, Ukrajna, Tajvan, Mexikó, Colombia, Magyarország, Puerto Rico
-
PfizerBefejezvePlakkos PsoriasisEgyesült Államok
-
PfizerMegszűntColitis ulcerosaSpanyolország, Egyesült Államok, Koreai Köztársaság, Szerbia, Kanada, Lengyelország, Japán, Franciaország, Új Zéland, Dél-Afrika, Németország, Szlovákia, Magyarország, Belgium, Csehország, Olaszország, Hollandia, Orosz Föderáció és több
-
PfizerBefejezveÍzületi gyulladás, rheumatoidEgyesült Államok, Németország, Koreai Köztársaság, Spanyolország, Cseh Köztársaság, Mexikó, Lengyelország, Orosz Föderáció
-
PfizerBefejezveSzáraz szem szindrómákKoreai Köztársaság, Japán
-
PfizerAktív, nem toborzóFiatalkori idiopátiás ízületi gyulladásEgyesült Államok, Spanyolország, Belgium, Kanada, India, Pulyka, Ausztrália, Mexikó, Dél-Afrika, Németország, Kína, Lengyelország, Szlovákia, Izrael, Magyarország, Argentína, Brazília, Orosz Föderáció, Ukrajna, Egyesült Királyság, Olaszorsz... és több
-
Brigham and Women's HospitalToborzás