Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
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
1 other identifier
interventional
302
1 country
11
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Aug 2007
Typical duration for phase_2 rheumatoid-arthritis
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 1, 2007
CompletedFirst Posted
Study publicly available on registry
October 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
December 30, 2009
CompletedApril 11, 2011
April 1, 2011
11 months
October 1, 2007
November 23, 2009
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (16)
Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period
Week 12
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period
Baseline, Week 12
- +11 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo administered subcutaneously every other week
Adalimumab 80 mg
EXPERIMENTALAdalimumab 80 mg administered subcutaneously every other week
Adalimumab 40 mg
EXPERIMENTALAdalimumab 40 mg administered subcutaneously every other week
Interventions
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
Adalimumab 40 mg administered subcutaneously every other week for 104 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (11)
Site Reference ID/Investigator# 6259
Hefei, AN, 230022, China
Site Reference ID/Investigator# 6266
Beijing, 100730, China
Site Reference ID/Investigator# 6241
Beijing, 100853, China
Site Reference ID/Investigator# 6243
Guangzhou, 510260, China
Site Reference ID/Investigator# 6247
Guangzhou, 510630, China
Site Reference ID/Investigator# 6262
Harbin, 150001, China
Site Reference ID/Investigator# 6248
Hepingjiebeikou, 100029, China
Site Reference ID/Investigator# 6250
Shanghai, 200001, China
Site Reference ID/Investigator# 6828
Shanghai, 200032, China
Site Reference ID/Investigator# 6333
Shanghai, 200433, China
Site Reference ID/Investigator# 6264
Xi'an, 710032, China
Related Publications (1)
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
PMID: 27338778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Laura Redden, MD, PhD
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 1, 2007
First Posted
October 3, 2007
Study Start
August 1, 2007
Primary Completion
July 1, 2008
Study Completion
December 1, 2009
Last Updated
April 11, 2011
Results First Posted
December 30, 2009
Record last verified: 2011-04