IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic Disease.

Completed

• Conditions: Recent onset rheumatoid arthritis (RA) and undifferentiated arthritis (UA)

• Registration Number: NL-OMON20953
• Lead Sponsor: Abbott

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 610

Inclusion Criteria

1. Patients >=18 years of age with either RA according to the revised criteria of the American College of Rheumatology (ACR) (29) of less than two years duration, or UA, suspected by the rheumatologist to have an early presentation of RA;

2. All patients must have at least one (out of 66) swollen joint and at least one other (out of 68) painful joint, and a combined DAS of >1.6;

Exclusion Criteria

1. Previous therapy with DMARDs or with corticosteroids (exception: one dose of parenteral corticosteroids within the last 6 months, but not within the last 2 months, or an oral dose of prednisone of =<10 mg/day for =< 2 weeks within the same period allowed);

2. Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients in remission (DAS <1.6), functional ability as measured by HAQ, radiological damage progression as measured by Sharp/van der Heijde score.

Secondary Outcome Measures

Name	Time	Method
Quality of life, as measured with MACTAR, SF-36, EuroQol, Time-trade-off. Costs. ACR arthritis core-set.