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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01172639
Date of registration: 28/07/2010
Prospective Registration: No
Primary sponsor: P. Verschueren
Public title: Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Scientific title: A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Date of first enrolment: February 2009
Target sample size: 400
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01172639
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Belgium
Contacts
Name:     Patrick Verschueren, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Universitaire Ziekenhuizen Leuven
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Leflunomide
Drug: Methotrexate
Drug: Prednisone
Drug: Sulfasalazine
Primary Outcome(s)
Remission According to DAS28-CRP at Week 104 [Time Frame: week 104]
Remission According to DAS28-CRP at Week 16 [Time Frame: week 16]
Remission According to DAS28-CRP at Week 52 [Time Frame: week 52]
Secondary Outcome(s)
Clinically Significant Change in HAQ Score [Time Frame: Baseline-week104]
Remission According to SDAI (Simple Disease Activity Index) at Week 16 [Time Frame: week 16]
Remission According to SDAI at Week 104 [Time Frame: week 104]
Remission According to SDAI at Week 52 [Time Frame: week 52]
Secondary ID(s)
2008-007225-39
CareRA
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Agentschap voor Innovatie door Wetenschap en Technologie
Ethics review
Results
Results available: Yes
Date Posted: 10/12/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01172639
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