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

This study has been terminated.
(AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00805467
First received: December 5, 2008
Last updated: October 22, 2013
Last verified: October 2013
  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 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 ]

Enrollment: 624
Study Start Date: August 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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

  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

  Show 75 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Chris O'Brien, MD, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00805467     History of Changes
Other Study ID Numbers: C-935788-012, D4300C00021
Study First Received: December 5, 2008
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Bulgaria: Bulgarian Drug Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombia: Ethics Committee (Ethic Committee of each institution)
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: Ethics Committee (each site submits to their local EC).
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ministry of Health (Secretaria de Salud, SSA)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency

Keywords provided by AstraZeneca:
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014