Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Placebo (Biological); Adalimumab 80 mg (Biological); Adalimumab 40 mg (Biological)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Laura Redden, MD, PhD, Study Director, Affiliation: Abbott
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period
Secondary outcome: Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind PeriodNumber of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period 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 Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Detailed description:
This was a multi-center, Phase 2/3, randomized, double-blind (DB), parallel group, placebo
controlled, safety and efficacy study in adult Chinese RA subjects. The duration of the
study was approximately 116 weeks. This included a 4-week (28 days) Screening period, a
12-week Double-Blind (DB) period, a 90-week Open-Label (OL) Period, and a 10-week (70 days)
Follow-up period. The 70-day Safety Follow-up period was initiated after the last dose of
study medication.
During the DB period, 302 Chinese subjects with RA and concomitantly treated with MTX were
enrolled at 11 clinical sites located throughout China. Subjects were randomly assigned to
one of the three treatment groups in a 2: 2:1 ratio: 80 mg adalimumab, 40 mg adalimumab, or
placebo. From Week 0 to Week 10, subjects received blinded study drug. Subjects who
successfully participated and completed Week 12 of the DB portion of the study participated
in the OL period. All subjects in the OL period received adalimumab 40 mg. Throughout the
study, the study drug was administered subcutaneously (SC) every other week (eow).
Subjects that completed the Week 24 visit, prior to the approval of Protocol Amendment 1,
had 70 days from the last dose of study drug to re-enter the study. The Investigator
confirmed that the subject did not develop any of the exclusion criteria and completed the
procedures defined by the OL Screening visit.
Results through Week 24 of this study were presented in the regulatory dossier for the
marketing authorization application of Humira in China, fulfilling the requirement for
clinical data in Chinese patients. However, in order to continue to provide treatment to
patients who responded well to adalimumab, subjects had the option to continue in the OL
extension of this study until Week 92.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Site Reference ID/Investigator# 6241, Beijing 100853, China
Site Reference ID/Investigator# 6266, Beijing 100730, 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# 6333, Shanghai 200433, China
Site Reference ID/Investigator# 6828, Shanghai 200032, China
Site Reference ID/Investigator# 6264, Xi'an 710032, China
Site Reference ID/Investigator# 6259, Hefei, Anhui 230022, China
Additional Information
Starting date: August 2007
Last updated: April 7, 2011
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