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
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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