Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)
Overview
- Phase
- Not Applicable
- Intervention
- Adalimumab
- Conditions
- Rheumatoid Arthritis
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 346
- Primary Endpoint
- Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This was a single-arm, multicenter, open label, prospective cohort study (post-marketing observational study) to determine the effectiveness and safety of adalimumab in combination with high-dose methotrexate (≥12 mg/week) in participants with rheumatoid arthritis in a routine clinical setting in Japan.
Detailed Description
Study assessments occurred at baseline, Week 12, Week 24, Week 52, Week 76, and Week 104. Most participants received 40 mg of adalimumab every other week during the study. Two participants started at 40 mg of adalimumab every other week, and increased to 80 mg every other week. A few participants had a different dose regimen: 40 mg every three weeks for 3 participants; 40 mg every four weeks for 1 participant; and 40 mg every other week with a switch to 50 mg every three weeks for 4 subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The participants of this study were rheumatoid arthritis (RA) patients for whom adalimumab was prescribed. They must have met the following conditions:
- •Disease duration of RA ≤2 years
- •Methotrexate (MTX) administration ≥3 months prior to starting adalimumab
- •Dose of MTX ≥12mg/week
- •Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) score \>3.2
Exclusion Criteria
- •Participants who had been previously treated with biologics (including tumor necrosis factor \[TNF\] inhibitors and others)
Arms & Interventions
Participants treated with adalimumab
40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks
Intervention: Adalimumab
Outcomes
Primary Outcomes
Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52
Time Frame: At Week 52
The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hr) or C-reactive protein (CRP; mg/dL) level, and the participant's assessment of global disease activity (on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Secondary Outcomes
- Percentage of Participants With a Health Assessment Questionnaire Disability Index (HAQ-DI) Score < 0.5 at Week 104(At Week 104)
- Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score ≤ 3.3 at Week 104(At Week 104)
- Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score ≤ 2.8 at Week 104(At Week 104)
- Mean Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 104(Baseline and Week 104)
- Percentage of Participants With a Change From Baseline of ≤ 1.0 in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 104(Baseline and Week 104)