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

Study identifier:C-935788-012

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

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

Medical condition

Rheumatoid Arthritis

Phase

Phase 2

Healthy volunteers

Study drug

Fostamatinib Disodium (R935788)

Sex

All

Actual Enrollment

624

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Aug 2008

Primary Completion Date: 01 Aug 2013

Study Completion Date: 01 Aug 2013

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 May 2014 by AstraZeneca

Collaborators

Inclusion and exclusion 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:
a) unresolved Grade 2 or greater toxicity in a RA protocol studying R788
b) uncontrolled or poorly controlled hypertension;
c) recent (within past 2 months) serious surgery or infectious disease;
d) 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;
e) known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;
f) interstitial pneumonitis or active pulmonary infection;
g) 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.

No locations available

Arms	Assigned Interventions
Experimental: 1 R935788 50 mg tablet, orally, twice-a-day	Drug: Fostamatinib Disodium (R935788) 50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD Other Name: R935788
Experimental: 2 R935788 100 mg tablet, orally, twice-a-day	Drug: Fostamatinib Disodium (R935788) 50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD Other Name: R935788
Experimental: 3 R935788 100 mg tablet, orally, once-a-day	Drug: Fostamatinib Disodium (R935788) 50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD Other Name: R935788
Experimental: 4 R935788 150 mg tablet, orally, once-a-day	Drug: Fostamatinib Disodium (R935788) 50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD Other Name: R935788

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

www.taskistudy.com null

[email protected]

Investigators

Principal Investigator

Chris O'Brien

Astra Zeneca