A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFa Chimeric Monoclonal Antibody (infliximab, Remicade®) in Combination with Methotrexate in Patients with Very Early Inflammatory Arthritis (DINORA Study)

Phase 3

Completed

• Conditions: Rheumatoid arthritis-rheumatic disease; 10003816; 10023213

• Registration Number: NL-OMON31097
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1) Men and women, >= 18 and <= 75 years of age
2) The presence of arthritis:
a) Must be established in a rheumatology center,
b) Must be present in at least 2 joints of the 66 joint count
c) Without any previous episodes of inflammatory joint disease
3) Duration of symptoms :
a) Must be 2 weeks at least
b) Must be 16 weeks at most

Exclusion Criteria

*previous treatment with corticoseroids or DMARD's
*positive tuberculosis test

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Comparison of presence of clinical remission between treatment with infliximab<br /><br>plus MTX versus MTX monotherapy and supportive treatment only at end of<br /><br>infliximab therapy, i.e. at at least 2 consecutive visits after month 3 during<br /><br>the first 54 weeks. </p><br>