Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, ascending dose, dose ranging study to evaluate up to three doses of R935788 (50 mg bid, 100 mg bid and 150 mg bid). Approximately 180 patients who have had rheumatoid arthritis for a minimum of 12 months and who have been receiving a weekly methotrexate (MTX) dose for a minimum of 6 months will be enrolled into the study.

Key facts

Study ID

NCT00326339

Run by

Rigel Pharmaceuticals

People needed

189

Starts

2006-08-01

Expected to finish

2007-12-01

Last updated by the study team

2009-04-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must give written informed consent by signing an IRB-approved Informed Consent Form (ICF) prior to admission to this study.
• Males and females, 18 to 75 years of age, with active RA for at least 12 months (functional class I-III, e.g., not bed or wheelchair-bound) who have been receiving weekly doses of methotrexate (10-25 mg/week) for a minimum of 180 days, and who have been receiving a stable MTX dose of at least 15 mg without any change in route or change in folic acid supplementation for at least 30 days.
• Active RA is defined as the presence of (a)6 swollen joints (28 joint count); AND (b)6 tender joints (28 joint count); AND (c) CRP level > ULN for the central reference laboratory.
• Patient may receive up to 10 mg per day of oral prednisone or steroid equivalent, NSAID therapy, hydroxychloroquine, chloroquine, minocycline, sulfasalazine, and doxycycline. The dose(s) must have been stable for at least 30 days and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements.
• Females of childbearing potential must be fully informed of the potential for methotrexate and R788 to adversely affect the fetus and must agree to use adequate (2 methods) contraception during the study. 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 is in otherwise good health as determined by the Investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period, including the absence of clinically significant findings, such as HIV, HBV or HCV, interstitial pneumonitis or active pulmonary infection, on chest X-ray taken within 6 months prior to screening and a negative TB skin test, or abnormal liver function defined as known ALT >1.2xULN within the past 90 days.
• 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 (these will be included in an exclusion log).
• The patient has a history of substance abuse, drug addiction or alcoholism.
• The patient is unable to abstain from alcohol during the study.
• The patient has a recent (past 5 years) history of, or treatment for, a malignancy other than basal skin cancer.
• The patient has received any investigational medication within 30 days prior to admission to the study.
• Any patient who has received any of the following treatments must abide by the indicated washout period:
• oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to Day 1 dosing
• cyclosporine, abatacept, etanercept, infliximab or adalimumab require a 60 day washout period prior to Day 1 dosing
• leflunomide requires a 60 day washout period prior to screening, unless the patient has undergone cholestyramine washout at least 30 days prior to Day 1 dosing
• cyclophosphamide requires a 180 day washout period prior to Day 1 dosing
• Rituxan requires a 180 day washout period and normal CD19 count prior to Day 1 dosing
• parenteral or intra-articular corticosteroids require a 30 day washout period prior to Day 1 dosing
• Patients with the following laboratory abnormalities: ALT > 1.2X ULN, creatinine > ULN, a neutrophil count < 2,500/mm3 or lymphocyte count < 800/mm3, Hgb < 10 g/dL, platelet count < 125,000/mm3 are excluded.
• Patients should not use CYP3A4 inhibitors from within 3 days of randomization until the end of study. R406 is metabolized by CYP3A4, and ketoconazole increases the R406 AUC of a dose of R788 by approximately 2 fold.
• Patients should not use CYP3A4 inducers from within 3 days of randomization until the end of the study. Although glucocorticoids are inducers, a stable dose of no more than 10 mg/day is allowed.

Where it is running

• Pacific Arthritis Center Medical Group — Santa Maria, California, United States
• DMI research — Ocala, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Arthritis & Osteoporosis Treatment Center — Orange Park, Florida, United States
• Arthritis Associates Inc. — Orlando, Florida, United States
• Arthritis Research of Florida, Inc. — Palm Harbor, Florida, United States
• Arthritis Research of Florida — Palm Harbor, Florida, United States
• Lovelace Scientific Resources — Sarasota, Florida, United States
• The Center for Arthritis and Rheumatic Diseas — South Miami, Florida, United States
• Coeur d'Alene Arthritis Clinical Trials — Coeur d'Alene, Idaho, United States
• The Arthritis Center — Springfield, Illinois, United States
• MMG Clinical Research — South Bend, Indiana, United States
• Phase III Clinical Research — Fall River, Massachusetts, United States
• Michigan Arthritis Research Center — Brighton, Michigan, United States
• Westroad Medical Group — Omaha, Nebraska, United States
• NC Arthritis & Allergy Care Center — Raleigh, North Carolina, United States
• Clinical Research Division — Mayfield Village, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• East Penn Rheumatology Associates — Bethlehem, Pennsylvania, United States
• Altoona Ctr. for Clinical Research — Duncansville, Pennsylvania, United States
• Clinical Research Center of Reading LLP — West Reading, Pennsylvania, United States
• Low Country Rheumatology — Charleston, South Carolina, United States
• Arthritis Clinic — Jackson, Tennessee, United States
• SCRI — Memphis, Tennessee, United States
• Austin Rheumatology Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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