Information sheet on the clinical study - LEF15
Main indication
Rheumatoid arthritis
Study Name (Study Type)
LEF15 (Observational study)
Study sponsor
MEDAC Gesellschaft für klinische Spezialpräparate GmbH
Registration number
None
FOR RUSH READERS:
Study investigating the use, effectiveness, and tolerability of leflunomide (an antirheumatic drug) in patients with active rheumatoid arthritis in routine clinical practice. The study is a non-interventional observational study and has no influence on the treatment method prescribed by the physician.
DETAILED INFORMATION
Study Title
Multicenter, prospective, non-interventional study on the effect of Leflunomide medac 15 mg film-coated tablets on the DAS28 in patients with active rheumatoid arthritis in routine clinical practice.
Which conditions are being treated in the study?
Active rheumatoid arthritis.
Are specific subgroups of patients with one of the mentioned conditions being treated?
- Patients with moderate to high disease activity (DAS28 > 3.2)
- Patients with low disease activity at most (DAS28 ≤ 3.2)
Background on the study medication
Leflunomide is a long-acting immunosuppressant used as a first-line treatment for rheumatic diseases.
Study Protocol
The observation period is 24 weeks. During this period, patients will be examined during a total of 3 visits.
Inclusion criteria
- Age at enrollment > 18 years
- Planned treatment with leflunomide 15 mg
- Patients with rheumatoid arthritis
- Reliable contraception
Exclusion criteria
- Previous or current treatment with leflunomide 15 mg or biologics
- Contraindications as per the prescribing information
Your contacts: Investigators at the center and contact information
Dr. Andrea Himsel
Email: himsel@gp-ruesselsheim.de
Phone: 06142 88-1864
Responsible staff members at the study clinic
Heike Borchert (Study Coordinator)
Email: borchert@~@gp-ruesselsheim.de
Phone: 06142 88-1032