Paid Rheumatoid Arthritis (RA) Clinical Trial Now Enrolling at Achieve Clinical Research in Birmingham, Alabama; Accepting M/F Patients with RA Age 18
Summary
Birmingham, AL, October 16, 2013 --( Study Design This is a 48-week, double-blind, multiple dose, parallel group trial to compare the safety, efficacy, immunogenicity and tolerability of an experimental drug to Rituxan and MabThera in patients with moderately to severely active RA.They are also the primary source of rheumatoid factors (RFs) and anti-cyclic citrullinated peptide (anti-CCP) antibodies which contribute to the formation of immune complexes and complement activation in inflamed joints.There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.Study DesignThis is a 48-week, double-blind, multiple dose, parallel group trial to compare the safety, efficacy, immunogenicity and tolerability of an experimental drug to Rituxan and MabThera in patients with moderately to severely active RA.They are also the primary source of rheumatoid factors (RFs) and anti-cyclic citrullinated peptide (anti-CCP) antibodies which contribute to the formation of immune complexes and complement activation in inflamed joints.Thus, B cell targeted therapy could play an important role in RA through a reduction in the B cell count as well as a reduction in B cell-mediated downstream effects on other cell types involved in the inflammatory response.Primary ObjectivesThe primary objectives of this trial are:To show PK similarity of this new drug to MabThera and Rituxan and of Rituxan to MabThera (three-way PK similarity).To establish statistical equivalence of efficacy of this new drug and Rituxan/MabThera, in patients with moderately to severely active RAInclusion CriteriaMale or female participants, between 18 and 80 years of age, who have a diagnosis of moderately to severely active RA for at least 6 monthsPatients must have had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor.Positive for RF and/or anti-CCP antibodies.Current treatment for RA on an outpatient basis:-- Must be currently receiving and tolerating oral or parenteral MTX therapy at a dose of 15-25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose) for at least 12 weeks immediately prior to Day 1.-- Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or equivalent during the entire study (mandatory co-medication for MTX treatment).-- Biologic agents and DMARDs (other than MTX) must be withdrawn at least 2 weeks prior to Day 1.-- Leflunomide must be withdrawn at least 8 weeks prior to Day 1 or a minimum of 2 weeks prior to Day 1 if after 11 days of standard cholestyramine washout.-- If receiving current treatment with oral corticosteroids (other than intra-articular or parenteral), the dose must not exceed 10 mg/day prednisolone or equivalent.