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: May 23, 2014
Last verified: May 2014
  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:
  • Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category [ Time Frame: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years) ] [ Designated as safety issue: Yes ]
    AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event


Secondary Outcome Measures:
  • DAS28-CRP Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily

  • HAQ-DI Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.


Enrollment: 624
Study Start Date: August 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805467

  Show 76 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Chris O'Brien, MD, PhD AstraZeneca
  More Information

Additional 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
Results First Received: January 22, 2014
Last Updated: May 23, 2014
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 July 26, 2014