A Clinical Trial to Study the Effects of Revamilast in Patients With Rheumatoid Arthritis
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that
causes progressive damage to joints of the body, affecting the functional capacity. Effective
management of patients with RA requires a multidisciplinary approach. Despite the various
combinations, there is a significant population of RA patients who are not responding to
these combinations or showing inadequate response to methotrexate alone. Hence, there is a
need for a unique combination of drugs targeting different pathological process to yield the
best results in those patients where prognosis is poor. Combination of revamilast with first
line therapy like methotrexate could provide better treatment options to a larger population
of RA patients having moderate to severe disease and who are inadequately controlled on one
or the other DMARDs.
This is randomized, double-blind, placebo-controlled, parallel group study. The study will
include patients with active RA receiving stable and maximum tolerated dose of MTX.
Patients will be recruited after providing written informed consent. After screening and run
in period (single blind placebo for 4 weeks), patients will be randomized (meeting
randomization criteria) in 1:2:2:2 ratios to receive either one of three doses (Low, Medium
and High) of revamilast or placebo along with MTX.
The primary objective of the study is to determine the percentage of patients achieving ACR20
response at 12 weeks. Secondary objectives include determining percentage of patients with
ACR50 and ACR70 response, change in DAS-28 score, change in serum CRP and ESR values and
frequency and use of rescue medication.
During the treatment period, there will be 5 further study visits at week 2, week 4, week 8,
week 12, for efficacy, safety and tolerability assessment and visit at week 14 will be follow
up visit.