NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Rheumatoid arthritis
Date of first enrollment	26/11/2007
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Ocrelizumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26.

Outcome(s)

Primary Outcome	Percentage of patients with ACR20 response at week 24, and week 48
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Inclusion criteria: - adult patients, >=20 years of age; - rheumatoid arthritis for >=3 months; - inadequate response to previous or current treatment with at least one anti-TNF-alpha agent; - receiving either leflunomide or methotrexate for >=12 weeks, with a stable dose for the last 4 weeks. Exclusion criteria: - rheumatic autoimmune disease or inflammatory joint disease, other than RA; - any surgical procedure in past 12 weeks, or planned within 48 weeks of baseline.
Exclude criteria