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Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies
This study is enrolling participants by invitation only.
Sponsored by: Rigel Pharmaceuticals
Information provided by: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00805467
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Fostamatinib Disodium (R935788)
Phase II

MedlinePlus related topics: Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Rigel Pharmaceuticals:

Primary Outcome Measures:
  • The primary objective of this study is to investigate the long term safety of R788 in patients with Rheumatoid Arthritis (RA) who completed the treatment phase of Study C-935788-006X (C-788-006X), C-935788-010 (C-788-010), or C-935788-011 (C-788-011). [ Time Frame: ≥12 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary objective of this study is to investigate the long term efficacy of R788 in patients with RA who completed the treatment phase of Study C-788-006X, C-788-010, or C-788-011. [ Time Frame: ≥12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
2: Experimental
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
3: Experimental
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
4: Experimental
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805467

Locations
United States, California
San Diego Arthritis Medical Clinic
San Diego, California, United States, 92108,
United States, Indiana
Memorial Medical Group Clinical Research Inst
South Bend, Indiana, United States, 46601,
United States, Oklahoma
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States, 73103,
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Study Director: Daniel B Magilavy, MD Rigel Pharmaceuticals
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Rigel Pharmaceuticals, Inc. ( Daniel B. Magilavy, MD/Vice President, Clinical Development )
Study ID Numbers: C-935788-012
Study First Received: December 5, 2008
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00805467  
Health Authority: United States: Food and Drug Administration

Keywords provided by Rigel Pharmaceuticals:
RA

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009