Rheumatoid Arthritis Clinical Trial
Official title:
A Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
Verified date | April 2011 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
A study to assess the safety and efficacy of adalimumab administered as a subcutaneous injection in adult Chinese subjects with rheumatoid arthritis and treated with methotrexate
Status | Completed |
Enrollment | 302 |
Est. completion date | December 2009 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Met ACR criteria for diagnosis of active rheumatoid arthritis (RA) and have had at both the Screening visit and Week 0 visit at least four swollen joints (out of 66 assessed) and at least six tender joints(out of 68 assessed) - Subjects must have failed prior treatment with one or more disease-modifying antirheumatic drugs (DMARDs) - DMARDs (other than methotrexate [MTX]) must have been discontinued for >= 28 days or at least 5 half-lives, whichever is greater, before the Week 0 visit - Traditional Chinese Medicines must have been discontinued for >= 28 days before the Week 0 visit - Subjects must have received at least three months of treatment with MTX (minimum 7.5 mg/week) and remained on a stable dose of MTX for >= 28 days prior to the Screening visit - Glucocorticoids equivalent to <= 10 mg of prednisone and prednisone equivalent must have remained unchanged for at least 28 days prior to the Week 0 visit - Must have been able and willing to give written informed consent and to comply with the requirements of this study protocol Exclusion Criteria: - A history of, or current, acute inflammatory joint disease of different origin (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years - Wheelchair-bound or bedridden - Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit - Intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the Screening visit - Prior treatment with any TNF antagonist, including adalimumab - Subject considered by the investigator, for any reason, to be an unsuitable candidate - Female subject who is pregnant or breast-feeding or considering becoming pregnant |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Site Reference ID/Investigator# 6241 | Beijing | |
China | Site Reference ID/Investigator# 6266 | Beijing | |
China | Site Reference ID/Investigator# 6243 | Guangzhou | |
China | Site Reference ID/Investigator# 6247 | Guangzhou | |
China | Site Reference ID/Investigator# 6262 | Harbin | |
China | Site Reference ID/Investigator# 6259 | Hefei | Anhui |
China | Site Reference ID/Investigator# 6248 | Hepingjiebeikou | |
China | Site Reference ID/Investigator# 6250 | Shanghai | |
China | Site Reference ID/Investigator# 6333 | Shanghai | |
China | Site Reference ID/Investigator# 6828 | Shanghai | |
China | Site Reference ID/Investigator# 6264 | Xi'an |
Lead Sponsor | Collaborator |
---|---|
Abbott |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period | American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period. | Week 12 | No |
Secondary | Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period | American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period. | Week 12 | No |
Secondary | Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period | American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. | Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period | American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. | Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period | American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. | Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period | Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period. | Baseline, Week 12 | No |
Secondary | Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period | Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period. | Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period | Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period. | Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period | Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period. | Baseline, Week 12 | No |
Secondary | Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period | Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. | Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period | Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. | Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period | Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. | Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period | HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period. | Baseline, Week 12 | No |
Secondary | Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period | HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties). | Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period | SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status. | Baseline, Week 12 | No |
Secondary | Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period | SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status. | Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Secondary | Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period | SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status. | Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |