COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA

Phase 1

• Conditions: early active Rheumatoid Arthritis, previously untreated with DMARDs; MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-004054-41-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-15
• Study Completion: 2022-07-01
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 276

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

-Previous treatment with:
oMTX or leflunomide
ocyclophosphamide, azathioprine or cyclosporine
osulphasalazine (SSZ) for more than 3 weeks
ohydroxychloroquine for more than 6 weeks
ooral GC for more than 4 weeks within 4 months before screening
ooral GC at a daily dosage of more than 10 mg prednisone equivalent within 4 weeks before baseline
ooral GC at a daily dosage equal to or less than 10 mg prednisone equivalent within 2 weeks before baseline
ointra-articular GC within 4 weeks before BL
oan 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified