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Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan

23 aprile 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

487

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Giappone
      • Chiba, Giappone, 260-8712
        • National Hospital Organization Chiba-East Hospital
      • Fukuoka, Giappone, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Giappone, 810-0001
        • Kondo clinic for rheumatism and orthopaedics
      • Fukuoka, Giappone, 812-0025
        • Medical Co.LTA PS Clinic
      • Fukusima, Giappone, 960-8251
        • Fukusima Daiichi Hospital
      • Hiroshima, Giappone, 730-0017
        • Hiroshima Rheumatology Clinic
      • Kumamoto, Giappone, 862-0976
        • Kumamoto Orthopaedic Hospital
      • Kyoto, Giappone, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Kyoto, Giappone, 606-8507
        • Kyoto University Hospital
      • Miyagi, Giappone, 982-0032
        • Sendai Taihaku Hospital
      • Nagasaki, Giappone, 852-8501
        • Nagasaki University Hospital of Medicine and Dentistry
      • Niigata, Giappone, 951-8520
        • Niigata University Medical & Dental Hospital
      • Oita, Giappone, 870-0823
        • A Medical Corporation Oribe Rheumatism Internist Clinic
      • Osaka, Giappone, 530-8480
        • The Tazuke Kofukai Medical Research Institute Kitano Hospital
      • Saitama, Giappone, 336-8522
        • Saitama City Hospital
      • Shinjuku-ku, Tokyo, Giappone, 160-8582
        • Keio University Hospital
    • Aichi
      • Nagoya, Aichi, Giappone, 466-8560
        • Nagoya University Hospital
      • Nagoya, Aichi, Giappone, 460-0001
        • National Hospital Organization Nagoya Medical Center
    • Chiba
      • Narashino, Chiba, Giappone, 275-8580
        • Chiba-ken Saiseikai Narashino Hospital
      • Yotukaidou, Chiba, Giappone, 284-0003
        • Shimoshizu National Hospital
    • Fukuoka
      • Iiduka, Fukuoka, Giappone, 820-8505
        • Aso Iizuka Hospital
      • Kitakyusyu, Fukuoka, Giappone, 807-8555
        • University of Occupational and Environmental Health Hospital
      • Kurume, Fukuoka, Giappone, 830-8543
        • St. Mary's Hospital
      • Sawara-ku, Fukuoka, Giappone, 814-0002
        • SHONO Rheumatism Clinic
    • Gunma
      • Takasaki, Gunma, Giappone, 370-0053
        • Inoue Hospital
    • Hiroshima
      • Higashihiroshima, Hiroshima, Giappone, 739-0002
        • Higashihiroshima Memorial Hospital
      • Hiroshima-city, Hiroshima, Giappone, 730-8619
        • Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
    • Hokkaido
      • Asahikawa, Hokkaido, Giappone, 078-8243
        • Katayama Orthopedic Rheumatology Clinic
      • Sapporo, Hokkaido, Giappone, 060-8648
        • Hokkaido University Hospital
      • Sapporo, Hokkaido, Giappone, 060-8604
        • Sapporo City General Hospital
      • Sapporo, Hokkaido, Giappone, 063-0811
        • Hokkaido Medical Center for Rheumatic Diseases
    • Hyogo
      • Nishinomiya, Hyogo, Giappone, 663-8501
        • The Hospital of Hyogo College of Medicine
    • Ibaraki
      • Hitachi-shi, Ibaraki, Giappone, 316-0035
        • Taga General Hospital
      • Tsukuba, Ibaraki, Giappone, 305-8576
        • Tsukuba University Hospital
    • Kanagawa
      • Sagamihara, Kanagawa, Giappone, 252-0392
        • National Hospital Organization Sagamihara National Hospital
    • Kumamoto
      • Koushi, Kumamoto, Giappone, 861-1196
        • Kumamoto Saishunso National Hospital
    • Mie
      • Tsu, Mie, Giappone, 514-1101
        • National hospital Organization Mie Chuou Medical Center
    • Miyagi
      • Sendai, Miyagi, Giappone, 983-0833
        • Hikarigaoka Spellman Hospital
    • Nagasaki
      • Ohmura, Nagasaki, Giappone, 856-0835
        • National Hospital Organization Nagasaki Medical Center
      • Sasebo, Nagasaki, Giappone, 857-1195
        • Sasebo Chuo Hospital
    • Nara
      • Kashihara, Nara, Giappone, 634-0007
        • Higami hospital
    • Osaka
      • Kawachinagano, Osaka, Giappone, 586-8521
        • National Hospital Organization Osaka Minami Center
    • Saga
      • Ureshino, Saga, Giappone, 843-0393
        • Ureshino Medical Center
    • Saitama
      • Kawagoe-shi, Saitama, Giappone, 350-8550
        • Saitama Medical Center
      • Kitamoto, Saitama, Giappone, 364-8501
        • Kitasato University Kitasato Institute Medical Center Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Giappone, 430-8558
        • Seirei Hamamatsu General Hospital
    • Tokyo
      • Arakawa-ku, Tokyo, Giappone, 116-8567
        • Tokyo Women's Medical University Medical Center East
      • Bunkyo-ku, Tokyo, Giappone, 113-8431
        • Juntendo University Hospital
      • Bunkyo-ku, Tokyo, Giappone, 113-8519
        • Tokyo Medical And Dental University Hospital, Faculty of Medicine
      • Bunkyo-ku, Tokyo, Giappone, 113-8655
        • The University of Tokyo Hospital
      • Chiyoda-ku, Tokyo, Giappone, 101-0062
        • Sasaki Foundation Kyoundo Hospital
      • Koto-ku, Tokyo, Giappone, 136-0075
        • Juntendo Tokyo Koto Geriatric Medical Center
      • Meguro-ku, Tokyo, Giappone, 152-8902
        • National Hospital Organization Tokyo Medical Center
      • Musashimurayama-shi, Tokyo, Giappone, 208-0011
        • National Hospital Organization Murayama Medical Center
      • Setagaya-ku, Tokyo, Giappone, 155-0031
        • Fukuhara Hospital
      • Shinjyuku-ku, Tokyo, Giappone, 162-0054
        • Tokyo Women's Medical University, Institute of Rheumatology

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

20 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: CP-690,550
Droga: CP-690,550
5 mg BID up to 10 mg BID until launch

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2008

Completamento primario (Effettivo)

1 dicembre 2013

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

7 febbraio 2008

Primo inviato che soddisfa i criteri di controllo qualità

15 aprile 2008

Primo Inserito (Stima)

18 aprile 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 maggio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 aprile 2015

Ultimo verificato

1 aprile 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A3921041

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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