At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Optimization of Treatment With Adalimumab (HUMIRA): A Multi-center, Randomized, Single Blind, Controlled Clinical Trial
In Brief
An observational study evaluating DAS28-IOMS, 0SJ-IOMS, and 1 other intervention for Rheumatoid Arthritis (RA). Completed, enrolled 309 participants across 1 site.
Detailed Summary
The purpose of this trial is to assess the effect of two Intensive Outpatient Management Strategies (IOMS) versus Routine Care (RC) on the outcomes of patients with Rheumatoid Arthritis (RA) that are treated with adalimumab. This is a multi-center, randomized, controlled, parallel group, single (patient) blind trial. A total of 300 patients (100 per group) with RA will be recruited from approximately 40 sites across Canada.
Study Details
Timeline
Interventions
Investigators randomized to DAS28-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a DAS28 score of \< 2.4.
Investigators randomized to 0SJ-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a swollen joint count of 0.
Investigators randomized to RC will NOT be expected to adapt their therapeutic approaches to a pre-defined target. They will optimize adalimumab treatment according to individual patient's responses to treatment as per routine care and according to their own judgment.