Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Fostamatinib Disodium (R935788)
Intervention description: 50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 624.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RA

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.
    

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:

               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.