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

Erasmus University Medical Center0 sites300 target enrollmentOctober 27, 2020

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Erasmus University Medical Center
Enrollment: 300
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 27, 2020

End Date

December 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Erasmus University Medical Center

Eligibility Criteria

Inclusion Criteria

•1\. Newly diagnosed, DMARD\-naive RA patients, according to 2010 criteria
•2\. Between 18 and 80 years of age
•3\. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter as in standard practice

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:
•3\.1\. Evidence of ongoing infectious or malignant process obtained within 3 months prior to screening and evaluated by a qualified health care professional
•3\.2\. Pregnant or nursing (lactating) women
•3\.3\. 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.
•3\.4\. 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
•3\.5\. History of renal trauma, glomerulonephritis, or subjects with one kidney only, or a glomerular filtration rate (GFR) \< 30 ml/min.
•3\.6\. 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