A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00870467
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Double-blind adalimumab — BIOLOGICAL
    Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
  • Double-blind Placebo — DRUG
    Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
  • Open-label Adalimumab — BIOLOGICAL
    Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
  • Open-labelAdalimumabRescue — BIOLOGICAL
    Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26

Study Details

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

Key Dates

Start date
Mar 31, 2009
Status verified
Aug 2012
Primary completion
Mar 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
334 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: DB Placebo
    Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
  • Experimental: DB adalimumab
    Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
  • Experimental: DB Adalimumab/OL Adalimumab
    Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
  • Experimental: DB Placebo/OL Adalimumab
    Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
  • Experimental: DB Adalimumab/RE OL Adalimumab
    Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
  • Experimental: DB Placebo/RE OL Adalimumab
    Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Primary Outcome Measure

Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 [ Time Frame: Baseline, Week 26 ]

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