A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT01231321
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — DRUG
    Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Study Details

A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety measurements were performed throughout the study.

Key Dates

Start date
Dec 31, 2007
Status verified
Apr 2011
Primary completion
Feb 28, 2010
Completion
Feb 28, 2010

Study Design

Enrollment
100 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: adalimumab
    Adalimumab / pre-filled syringe 40 mg/0.8 ml

Primary Outcome Measure

Frequency of Adverse Events [ Time Frame: Up to 34 weeks (24 week study treatment plus 70-day follow-up period) ]

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