Phase 4
N=110
COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA
Arthritis, Rheumatoid
Bottom Line
View on ClinicalTrials.gov: NCT03649061 ↗Enrolled (actual)
110
Serious AEs
8.2%
Results posted
Jun 2025
Primary outcome: Primary: Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP) — 297.4; 300.7 units on a scale*week — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Etanercept 50 MG/ML (Drug); Leflunomide 10 milligram (MG) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- P. Verschueren
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP) |
297.4; 300.7 | <0.05 sig |
| SECONDARY Proportion of Insufficient Responders Achieving Remission (DAS28CRP<2.6) 28 Weeks After Randomization (Short Term Efficacy) to Either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction |
24; 32 | <0.05 sig |
| SECONDARY Proportion of Patients in Remission Defined as DAS28CRP<2.6 |
38; 30 | — |
| SECONDARY Proportion of Patients Achieving a EULAR Response |
42; 34; 52; 49 | — |
| SECONDARY Proportion of Patients Achieving a EULAR Response |
42; 34; 52; 49 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Response |
0.7; 0.9 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Response |
0.7; 0.9 | — |
| SECONDARY Radiographic Progression |
0.7; 0.8 | — |
| SECONDARY Radiographic Progression |
0.7; 0.8 | — |
Summary
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.
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-
Data sourced from ClinicalTrials.gov (NCT03649061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.