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

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Fostamatinib Disodium (R935788)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00805467

D4300C00021

C-935788-012

Details and patient eligibility

About

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.

Enrollment: 624 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. unresolved Grade 2 or greater toxicity in a RA protocol studying R788
  2. uncontrolled or poorly controlled hypertension;
  3. recent (within past 2 months) serious surgery or infectious disease;
  4. 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;
  5. known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;
  6. interstitial pneumonitis or active pulmonary infection;
  7. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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624 participants in 4 patient groups

1

Experimental group

Description:

R935788 50 mg tablet, orally, twice-a-day

Treatment:

Drug: Fostamatinib Disodium (R935788)

2

Experimental group

Description:

R935788 100 mg tablet, orally, twice-a-day

Treatment:

Drug: Fostamatinib Disodium (R935788)

3

Experimental group

Description:

R935788 100 mg tablet, orally, once-a-day

Treatment:

Drug: Fostamatinib Disodium (R935788)

4

Experimental group

Description:

R935788 150 mg tablet, orally, once-a-day

Treatment:

Drug: Fostamatinib Disodium (R935788)