Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.

Key facts

Study ID

NCT00665925

Run by

Rigel Pharmaceuticals

People needed

457

Starts

2008-05-01

Expected to finish

2009-06-01

Last updated by the study team

2016-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
• Males and females, 18 years of age or older, with active RA for at least 6 months prior to Day 1 dosing.
• Patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing.
• 'Patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing.
• Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
• The patient must otherwise be in good health as determined by the Investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. See exclusion criteria for specific exclusions.
• In the Investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol.

You may not qualify if…

• The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
• uncontrolled or poorly controlled hypertension;
• other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);
• recent (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease;
• recent history (past 5 years prior to Day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
• Hepatitis B ;
• Hepatitis C ;
• interstitial pneumonitis or active pulmonary infection on chest x-ray;
• Tuberculosis (TB): the TB skin test should be negative.
• known laboratory abnormalities.
• The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer=12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine=3 oz or 89 mL; 80 proof distilled spirits= 1.5 oz or 44 mL.
• The patient has been treated previously treated with R788 under a different protocol.

Where it is running

• Desert Medical Advances — Palm Desert, California, United States
• Arthritis & Osteoporosis Center, PC — Hamden, Connecticut, United States
• Cynthia Morgan — Washington D.C., District of Columbia, United States
• Florida Medical Research Institute — Gainsville, Florida, United States
• Paddock Park Clinical Research — Ocala, Florida, United States
• Jeffrey Poiley, MD — Orlando, Florida, United States
• Lovelace Scientific Resources — Sarasota, Florida, United States
• Rheumatology Associates, SC — Chicago, Illinois, United States
• Memorial Medical Group Clinical Research Inst — South Bend, Indiana, United States
• Center for Arthritis & Osteoporosis — Elizabethtown, Kentucky, United States
• The Osteoporosis & Clinical Trials Center — Hagerstown, Maryland, United States
• Fiechtner Research, Inc. — Lansing, Michigan, United States
• Westroads Medical Group — Omaha, Nebraska, United States
• North Carolina Arthritis & Allergy Care Center — Raleigh, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Health Research of Oklahoma — Oklahoma City, Oklahoma, United States
• Rheumatology Associates — Erie, Pennsylvania, United States
• Clinical Research Center of Reading, LLP — West Reading, Pennsylvania, United States
• Rheumatic Disease Associates — Willow Grove, Pennsylvania, United States
• Rheumatology Associates — Charleston, South Carolina, United States
• Austin Rheumatology & Research — Austin, Texas, United States
• Arthritis Center of South Texas — San Antonio, Texas, United States
• Arthritis Northwest, PLLC — Spokane, Washington, United States
• MNTranspH "Tsar Boris Treti" — Sofia, Gsof, Bulgaria
• Divison of Rheumatology Allergy and Immunology — La Jolla, California, United States

Full record on ClinicalTrials.gov

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