COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA (CareRA2020)

P. Verschueren

Status and phase: Completed; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Leflunomide 10 milligram (MG); Drug: Etanercept 50 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03649061

KCE-16002

2017-004054-41 (EudraCT Number)

Details and patient eligibility

About

In the Care in Rheumatoid Arthritis (CareRA) trial (NCT01172639) about 70% of early RA patients are in remission at the 2 year evaluation point independent of the combination scheme used.

Interesting to see is that the 30% of insufficient responders can be identified in an early stage of the treatment course.

The purpose of the present study is to investigate if, for patients with an insufficient response to a COBRA-Slim regimen, accelerated access to a short course of anti-TNF therapy already early after treatment initiation (from w8 until w32) could improve outcomes compared to a more traditional treat to target sequence.

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

standard COBRA-Slim induction

Active Comparator group

Description:

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.)

Treatment:

Drug: Leflunomide 10 milligram (MG)

COBRA-Slim Bio-induction

Experimental group

Description:

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.)

Treatment:

Drug: Etanercept 50 MG/ML