Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA

Phase 1

• Conditions: Active Rheumatoid Arthritis

• Registration Number: EUCTR2005-004582-41-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

•Male and female patients aged between 18 and 80 years.
•Diagnosis of rheumatoid arthritis (1987 revised ACR criteria) confirmed at least 6 months prior screening
•Persisting RA activity despite treatment with leflunomide for at least 16 weeks with 20 mg/day or 10 mg/day. Dose stable for four weeks prior to baseline
•Subjects with active RA at baseline defined as: DAS 28 >5.1
•Rheumatoid factor positive

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with inflammatory joint disease of different origin, mixed connective tissue disease, Reiter’s syndrome, psoriatic arthritis, systemic lupus erythematous, or any arthritis with onset prior to 16 years of age.
2.Suspicion of diagnosis of tuberculosis (positive tuberculosis test (>5mm induration if previous BCG or >10mm if no previous BCG) or abnormal chest x-ray).
3.Patients with concomitant medical condition which would in the investigator’s opinion compromise the patient’s ability to tolerate, absorb, metabolise or excrete the study medication.
4.Patients with serious infections within 3 month of enrollment (screening) or persistent infections.
5.Patients at significant risk of infection (e.g. leg ulceration, indwelling urinary catheter, septic joint within 1 year (or ever if prosthetic joint still in situ)).
6.Patients with malignancy (other than excised basal cell carcinoma) within the last 5 years before study entry (screening).
7.Patients with history of Felty’s syndrome, uncontrolled diabetes, uncontrolled hypertension, unstable ischaemic heart disease, active bowel disease, active peptic ulcer disease, recent stroke (within three month before study entry (screening)), or other condition which, in the opinion of the investigator, would put the patient at risk to participate in the study.
8.Known positive serology for hepatitis B or C, or HIV
9.Patients with acute major trauma.
10.Patients with body weight < 45 kg.
11.Clinically relevant cardiovascular, hepatic, neurologic (such as multiple sclerosis, optic neuritis etc.), endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
12.Impaired hepatic function, as shown by ALT or ALP more than or equal to 1,5 times the laboratory upper limit of normal or Serum albumin < 30 g/l.
13.Patients with significantly impaired bone marrow function as for example significant anaemia, leukopenia, neutropenia or thrombocytopenia.

Study & Design

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