At a glance
ClinicalIndex Comparison RecordN/ACompleted· 346 enrolled
Drug / intervention
Adalimumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)
In Brief
An observational study evaluating Adalimumab for Rheumatoid Arthritis. Completed, enrolled 346 participants.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedNov 2012
Primary CompletionApr 2018
TodayJul 2026
First PostedNov 29, 2012
Enrollment StartOct 11, 2012
Primary CompletionApr 16, 2018
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 13.6 years ago
Interventions
Adalimumabdrug
Pre-filled syringe, administered by subcutaneous injection