Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

Stopped early · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.

Key facts

Study ID

NCT00805467

Run by

AstraZeneca

People needed

624

Starts

2008-08-01

Expected to finish

2013-08-01

Last updated by the study team

2014-06-25

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
• Patients who are being treated in Study C-788-006X
• Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
• Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy
• 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 pregnancy test at the time of entry and at each laboratory determination.

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:
• unresolved Grade 2 or greater toxicity in a RA protocol studying R788
• uncontrolled or poorly controlled hypertension;
• recent (within past 2 months) serious surgery or infectious disease;
• recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
• known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;
• interstitial pneumonitis or active pulmonary infection;
• known laboratory abnormalities: ALT > 1.2 x ULN, creatinine >1.5x ULN, an ANC <2,500/mm3 or 2.5 x 109/L, lymphocyte count < 600/mm3 or 0.6 x 109L, Hgb < 9 g/dL or 5 mmol/L, platelet count <125,000/mm3 or 125 x 109/L are excluded.
• 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 is unable to report for clinical and laboratory monitoring as per protocol.

Where it is running

• Research Site — Palm Desert, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Maria, California, United States
• Research Site — Hamden, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Aventura, Florida, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Orange Park, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — South Miami, Florida, United States
• Research Site — Venice, Florida, United States
• Research Site — Boise, Idaho, United States
• Research Site — Coeur d'Alene, Idaho, United States
• Research Site — South Bend, Indiana, United States
• Research Site — Elizabethtown, Kentucky, United States
• Research Site — Cumberland, Maryland, United States
• Research Site — Hagerstown, Maryland, United States
• Research Site — Lansing, Michigan, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Roslyn, New York, United States
• Research Site — Smithtown, New York, United States
• Research Site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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