An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

AstraZeneca1 site in 1 country624 target enrollmentAugust 2008

ConditionsRheumatoid Arthritis

InterventionsFostamatinib Disodium (R935788)

DrugsFostamatinib Disodium (R935788)

Overview

Phase: Phase 2
Intervention: Fostamatinib Disodium (R935788)
Conditions: Rheumatoid Arthritis
Sponsor: AstraZeneca
Enrollment: 624
Locations: 1
Primary Endpoint: Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

August 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.