N/A
Completed N=346
Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice
Source: ClinicalTrials.gov NCT01736189 ↗Enrolled (actual)
346
Serious AEs
9.7%
Results posted
Jul 2019
Primary outcomePrimary: Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52 — 77.1; 61.1 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52 |
77.1; 61.1 | — |
| SECONDARY Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score ≤ 2.8 at Week 104 |
69.5 | — |
| SECONDARY Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score ≤ 3.3 at Week 104 |
73.4 | — |
| SECONDARY Percentage of Participants With a Health Assessment Questionnaire Disability Index (HAQ-DI) Score < 0.5 at Week 104 |
90.5 | — |
| SECONDARY Mean Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 104 |
0.2543 | — |
| SECONDARY Percentage of Participants With a Change From Baseline of ≤ 1.0 in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 104 |
84.3 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01736189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.