Leflunomide in Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00280644
• Date of registration: 19/01/2006
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Leflunomide in Rheumatoid Arthritis
• Scientific title: Efficacy of Leflunomide on Joint Inflammation and Destruction of Joint Integrity in Active Rheumatoid Arthritis (RA) Patients
• Date of first enrolment: April 2004
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00280644
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Edibe Taylan
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient who has diagnosis of rheumatoid arthritis based upon the ACR (American
College of Rheumatology) diagnostic criteria

- Patient who has not ARA functional class IV (ACR 1991 revised criteria). Active
disease defined as > 6 swollen or tender joints, by physician and as well as by
patient global assessment of disease activity as moderate or worse

- Patient who has active disease defined by a modified Disease Activity Score (DAS)>3.2

- At least one wrist joint with active disease, defined by clinically detectable
synovitis at that site due to technical facility of using wrist joint for
DEMRI (Dynamic Enhanced Magnetic Resonance Imaging)

- Patient who has received unchanged doses of oral corticosteroids (with a maximum dose
of 10 mg prednisone daily or steroid equivalent orally administered ) and
concomitant stable doses of nonsteroidal anti-inflammatory drugs for at least
4 weeks before entering the study

- Woman of childbearing potential,who is demonstrated not to be pregnant (by serum
pregnancy test) or breast feeding at screening visit, and who is agree to undergo
urine pregnancy testing monthly during the study, and serum pregnancy test at the end
of the treatment

- Woman of childbearing potential, who agrees to maintain an adequate mean of
contraception and not to get pregnant through the study and for 24 months after the
discontinuation of the treatment.Man wishing to father a child, who has a consent to
discontinue the treatment with study medication, will undergo a drug elimination
procedure

Exclusion Criteria:

- The patient who has ARA functional class IV

- The patient who has a history of other inflammatory joint disease, e.g. mixed
connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis,
Reiter's syndrome, systemic lupus erythematosus, sarcoidosis, history of Felty's
syndrome, or any arthritis with onset prior to 16 years of age

- The patient who has a congenital or acquired severe immunodeficiency, a history of
cancer or lymphoproliferative disease, or he/she has received total lymphoid
irradiation

- The patient who is in known HIV positive status defined by either a positive blood
test or clinical diagnosis

- The patient who has been sick with persistent infection or severe infection within 3
months of enrollment

- Known Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency

- The patient who has acute intermittent porphyria

- The patient who has hematopoietic disorder (haemoglobin < 9 g/dl, White Blood Cells <
3500/mm3, platelet count < 120.000/mm3)

- The patient who has impaired coagulation, on treatment with oral anti-coagulants

- The patient who has uncontrolled diabetes, unstable ischaemic heart disease, active
inflammatory bowel disease, active peptic ulcer disease or history of active peptic
ulcer disease during the previous 4 months (documented by gastroscopy or clinically
diagnosed by a physician), recent or history of major traumatic injury, history of
malignancy.

- The patient who has clinically relevant cardiovascular, hepatic, neurologic,
endocrine, or other major systemic disease making implementation of the protocol or
interpretation of the study results difficult

- Patients body weight is < 45 kg

- The patient who has received therapy within the previous 3 months with any
investigational drug, alkylating agents (e.g. cyclophosphamide, chlorambucil),
biological agents (e.g. interferon, monoclonal antibodies, growth factor, cytokines).

- The patient who has received other DMARD (Disease Modifying Antirheumatic Drugs)
therapy (D-penicillamine, oral or injectable gold, chloroquine, hydroxychloroquine,
cyclosporine,MTX) who hasn't been followed by a washout period of 28 days

- Patients who had a therapy of oral corticosteroids exceeding a prednisone equivalent
of 10 mg/day, parenteral or intra-articular corticoid injection, within the previous
4 weeks

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Leflunomide

Primary Outcome(s)

The proportion of patients responding according to "28-Joint Disease Activity Score" (DAS28) criteria (a 1.2 point increase compared with pretreatment values), C-Reactive Protein (CRP)

Secondary ID(s)

HWA486_4022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors