Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor AbbVie (prior sponsor, Abbott)
Start date September 2012
End date March 2017
Trial size 350 participants
Trial identifier NCT01736189, P13-684

Summary

In the usual clinical setting, patients with Rheumatoid Arthritis who receive adalimumab (Humira®) and high-dose Methotrexate (≥12 mg/week) will be investigated prospectively for effectiveness according to Disease Activity Score 28, modified Total Sharp Score, and other measures, as well as safety in terms of the incidence and pattern of occurrence of adverse drug reactions.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
those with an exposure

Primary Outcomes

Measure
Disease activity Score 28
time frame: at week 12
Disease activity Score 28
time frame: at week 24
Disease activity Score 28
time frame: at week 52

Secondary Outcomes

Measure
Clinical disease activity index
time frame: at week 12
Clinical disease activity index
time frame: at week 24
Clinical disease activity index
time frame: at week 52
Simplified disease activity index
time frame: at week 12
Simplified disease activity index
time frame: at week 24
Simplified disease activity index
time frame: at week 52
X-ray findings for hands and feet
time frame: at week 52
Health Assessment Questionnaire
time frame: at week 12
Health Assessment Questionnaire
time frame: at week 24
Health Assessment Questionnaire
time frame: at week 52
Number of patients with adverse events
time frame: at week 52

Eligibility Criteria

Male or female participants from 16 years up to 99 years old.

Inclusion Criteria: The subjects of this study are RA patients and to whom adalimumab is administered. They should be satisfying the following conditions: - Disease duration of RA ≤2 years - MTX administration ≥3 months - Dose of MTX ≥12mg/week - DAS28-CRP >3.2 Exclusion Criteria: - Patients who have been previously treated with biologics (including TNF inhibitors others)

Additional Information

Official title Special Investigation in Patients With Rheumatoid Arthritis (Combo Study : Adalimumab With High Dose MTX)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.