early active Rheumatoid Arthritis, previously untreated with DMARDs MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: etanercept
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 years and older - Diagnosis of RA as defined by the ACR/EULAR2010 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 - Able and willing to give written informed consent and to participate in the study - Understanding and able to write Dutch or French Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 385 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: - Previous treatment with: o MTX or leflunomide o cyclophosphamide, azathioprine or cyclosporine o sulphasalazine (SSZ) for more than 3 weeks o hydroxychloroquine for more than 6 weeks o oral GC for more than 4 weeks within 4 months before screening o oral GC at a daily dosage of more than 10 mg prednisone equivalent within 4 weeks before baseline o oral GC at a daily dosage equal to or less than 10 mg prednisone equivalent within 2 weeks before baseline o intra-articular GC within 4 weeks before BL o 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 Methotrexate - 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 - Alcohol or drug abuse - Active TB - Latent TB unless adequate prophylactic treatment is given - No access to the Belgian Health Insurance system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare in an early RA population with insufficient response (not achieving DAS28CRP=3.2 within 32 weeks) to COBRA-Slim remission induction, the long term effectiveness of accelerated access to a six-month course of anti-TNF therapy (etanercept) within a time window from w8 up to w32, versus further treatment adaptation according to the standard COBRA-Slim strategy.;Secondary Objective: Main secondary objective To investigate in insufficient responders to the COBRA-Slim regimen if accelerated access to a six-month course of anti-TNF therapy (etanercept), is leading to improved remission rates when compared to conventional treatment adaptation according to the COBRA-Slim strategy, 28 weeks after randomization into one of two treatment arms. Other secondary objectives: 1.To further determine the clinical efficacy of accelerated access to etanercept versus the standard COBRA-Slim strategy in terms of remission rates and functionality scales. 2.To compare radiographic progression between all treatment schemes. 3.To evaluate the side effects of the given treatments as evaluated according to the regulatory guidelines for marketed products. 4.To evaluate the primary outcome using the DAS28ESR instead of the DAS28CRP. ;Primary end point(s): Area under the curve of DAS28-CRP over 104 weeks (long term effectiveness) in insufficient responders randomized to either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction.;Timepoint(s) of evaluation of this end point: at week 104 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Main secondary outcome measure 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. Other secondary outcome measures The following analyses will be performed in the randomized early insufficient responder population (w8-w32) with or without accelerated access to a six-month course of etanercept. The same analyses will also be performed including the randomized groups of insufficient responders, each completed with an early responder control population. 1. Clinical efficacy: o Remission (DAS28CRP<2.6) at w104. o EULAR response at 28 weeks after randomization and at w104 o HAQ response at 28 weeks after randomization and at w104 2. Radiographic progression: X-ray evolution at w52 and w104 compared to BL as reviewed and evaluated by the central team. 3. Side effects: (S)ARs from BL until w104 4. To evaluate the primary outcome using the DAS28ESR instead of the DAS28CRP.;Timepoint(s) of evaluation of this end point: at 28 weeks after randomisation; at week 52; at week 64; at week104 | — |
Countries
Belgium
Contacts
Public ContactPatrick Verschueren
University Hospitals Leuven
Outcome results
None listed