COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA (CareRA2020)
Arthritis, Rheumatoid
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring COBRA-Slim, Accelerated access to anti-TNF, treat to target, remission induction
Eligibility Criteria
Inclusion Criteria:
- Age 18 years and older
- Diagnosis of RA as defined by the American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010 criteria for early RA
- Early RA defined by a diagnosis made ≤ 1 year ago.
- Use a reliable method of contraception for women of childbearing potential to be evaluated as in daily clinical practice
- Able and willing to give written informed consent and to participate in the study
- Understanding and able to write Dutch or French
Exclusion Criteria:
Previous treatment with:
- Methotrexate (MTX) or leflunomide
- cyclophosphamide, azathioprine or cyclosporine
- sulphasalazine (SSZ) for more than 3 weeks
- hydroxychloroquine for more than 6 weeks
- oral Glucocorticoids (GC) for more than 4 weeks within 4 months before screening
- oral GC at a daily dosage of more than 10 mg prednisone equivalent within 4 weeks before baseline
- oral GC at a daily dosage equal to or less than 10 mg prednisone equivalent within 2 weeks before baseline
- intra-articular GC within 4 weeks before BL
- an investigational drug for the treatment/prevention of RA
- History of chronic heart failure
- History of severe infections or chronic infection
- History of malignant neoplasm within 5 years
- Contra indications for GC
- Contra indications for TNF blocking agents
- Contra indications for MTX or leflunomide
- Psoriatic Arthritis
- Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
- Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice)
- Alcohol or drug abuse
- Active tuberculosis (TB)
- Latent TB unless adequate prophylactic treatment is given according to local guidelines
- No access to the Belgian Health Insurance system-
Sites / Locations
- Imelda Ziekenhuis Bonheiden
- AZ Herentals
- ZNA Jan Palfijn
- GHdC Saint Joseph
- Reuma centrum Genk
- Reuma Clinic Genk
- Reuma Instituut Hasselt
- CHU UCL Namur ASBL Site Godinne
- OLV Ziekenhuis Aalst
- Regionaal Ziekenhuis Heilig Hart Leuven
- UZ Leuven
- AZ Jan Portaels
- AZ St Lucas Brugge
- AZ Sint Jan Brugge
- UZ Brussel
- CHU Saint Pierre
- Cliniques Universitaire Saint Luc (UCL)
- Hôpital Erasme-ULB
- CHU Liège
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
standard COBRA-Slim induction
COBRA-Slim Bio-induction
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)