PeRsonalIzed MEdicine in Rheumatoid Arthritis (PRIMERA trial): a multicenter, single-blinded, randomized controlled trial comparing usual care with a tailor-made approach

Phase 4

Recruiting

• Conditions: Rheumatoid Arthritis; Symmetrical (small) joint inflammation with or without auto-antibodies; 10003816; 10013361

• Registration Number: NL-OMON49359
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

- Newly diagnosed, DMARD-naive RA patients, according to 2010 criteria
- Age >=18 years

Exclusion Criteria

1. Current or previous treatment of arthritis with DMARDs

2. Glucocorticoids (GCs) in the 3 months prior to randomization

3. (Relative) contraindications for study medication:
a. Evidence of ongoing infectious or malignant process obtained within 3 months
prior to screening and evaluated by a qualified health care professional.
b. Pregnant or nursing (lactating) women.
c. Female participants of child bearing potential and male participants whose
partner is of child bearing potential who are not willing to ensure that they
or their partner use effective contraception during the trial and for 3 months
thereafter as in standard practice.
d. History of clinically significant liver disease or liver injury as indicated
by abnormal liver function tests (LFT) such as aspartate aminotransferase/serum
glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ serum
glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, or serum
bilirubin. The Investigator should be guided by the following criteria: Any
single parameter may not exceed 2 x upper limit of normal (ULN). A single
parameter elevated up to and including 2 x ULN should be re-checked once more
as soon as possible, and in all cases, at least prior to
enrollment/randomization, to rule out laboratory error.
e. History of renal trauma, glomerulonephritis, or subjects with one kidney
only, or a glomerular filtration rate (GFR) < 30 ml/min.
f. Other underlying metabolic, hematologic, renal, hepatic, pulmonary,
neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which
in the opinion of the Investigator immunocompromises the patient and/or places
the patient at unacceptable risk for participation in an immunomodulatory
therapy.

4. Unable to understand, speak and write in Dutch.

Study & Design

• Study Type: Interventional
• Study Design: Not specified