Status:
COMPLETED
Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Lead Sponsor:
P. Verschueren
Collaborating Sponsors:
Agentschap voor Innovatie door Wetenschap en Technologie
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study introduced the principle of ...
Eligibility Criteria
Inclusion
- Diagnosis of RA as defined by the 1987 or 2010 revised American College of Rheumatology (ACR) criteria
- Early RA (less than 1 year)
- Use a reliable method of contraception for women of childbearing potential
- Able and willing to give written informed consent and participate in the study
Exclusion
- Previous treatment with DMARDs
- Previous treatment with oral corticosteroids at a dosage of more than 10 milligrams (mg) prednisone within 4 weeks before baseline
- Previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg prednisone within 2 weeks before baseline
- Previous treatment with oral corticosteroids for more than 4 weeks
- Previous treatment with Intra Articular corticosteroids within 4 weeks before baseline
- Previous treatment with an investigational drug for the treatment or prevention of RA
- Contraindications for corticosteroids
- Contraindications for DMARDs
- 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
- Alcohol or drug abuse
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01172639
Start Date
February 1 2009
End Date
June 1 2015
Last Update
January 22 2019
Active Locations (17)
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1
ASZ
Aalst, Belgium, 9300
2
OLV Ziekenhuis
Aalst, Belgium, 9300
3
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
4
AZ St Lucas
Bruges, Belgium, 8310