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

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

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Fostamatinib Disodium (R935788)

• Study Type: Interventional
• Enrollment (Actual): 624
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Research Site
  • Gent, Belgium
    • Research Site
  • Liege, Belgium
    • Research Site
• Bulgaria
  • Plovdiv, Bulgaria
    • Research Site
  • Ruse, Bulgaria
    • Research Site
  • Sofia, Bulgaria
    • Research Site
• Colombia
  • Barranquilla, Colombia
    • Research Site
  • Bogota, Colombia
    • Research Site
  • Bucaramanga, Colombia
    • Research Site
  • Medellín, Colombia
    • Research Site
• France
  • Bordeaux, France
    • Research Site
• Germany
  • Hamburg, Germany
    • Research Site
  • Leipzig, Germany
    • Research Site
  • Würzburg, Germany
    • Research Site
• Italy
  • Siena, Italy
    • Research Site
  • Udine, Italy
    • Research Site
• Mexico
  • Chihuahua, Mexico
    • Research Site
  • Cuernava, Mexico
    • Research Site
  • Del. Cuauhtemoc, Mexico
    • Research Site
  • Guadalajara, Mexico
    • Research Site
  • Leon, Mexico
    • Research Site
  • Mexcio, Mexico
    • Research Site
  • Mexico, Mexico
    • Research Site
  • Morelia, Mexico
    • Research Site
  • San Luis Potosí, Mexico
    • Research Site
• Peru
  • Jesus Maria, Peru
    • Research Site
  • Lima, Peru
    • Research Site
• Poland
  • Białystok, Poland
    • Research Site
  • Bytom, Poland
    • Research Site
  • Elblag, Poland
    • Research Site
  • Grodzisk Mazowiecki, Poland
    • Research Site
  • Krakow, Poland
    • Research Site
  • Lublin, Poland
    • Research Site
  • Toruń, Poland
    • Research Site
  • Wroclaw, Poland
    • Research Site
  • Zyrardów, Poland
    • Research Site
• Romania
  • Brailari, Romania
    • Research Site
  • Bucuresti, Romania
    • Research Site
  • Cluj-Napoca, Romania
    • Research Site
  • Sf. Gheorghe, Romania
    • Research Site
  • Sibiu, Romania
    • Research Site
• United States
  • California
    • La Jolla, California, United States
      • Research Site
    • Palm Desert, California, United States
      • Research Site
    • Palo Alto, California, United States
      • Research Site
    • San Diego, California, United States
      • Research Site
    • Santa Maria, California, United States
      • Research Site
  • Connecticut
    • Hamden, Connecticut, United States
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States
      • Research Site
  • Florida
    • Aventura, Florida, United States
      • Research Site
    • Boca Raton, Florida, United States
      • Research Site
    • Gainesville, Florida, United States
      • Research Site
    • Ocala, Florida, United States
      • Research Site
    • Orange Park, Florida, United States
      • Research Site
    • Orlando, Florida, United States
      • Research Site
    • South Miami, Florida, United States
      • Research Site
    • Venice, Florida, United States
      • Research Site
  • Idaho
    • Boise, Idaho, United States
      • Research Site
    • Coeur D'Alene, Idaho, United States
      • Research Site
  • Indiana
    • South Bend, Indiana, United States
      • Research Site
  • Kentucky
    • Elizabethtown, Kentucky, United States
      • Research Site
  • Maryland
    • Cumberland, Maryland, United States
      • Research Site
    • Hagerstown, Maryland, United States
      • Research Site
  • Michigan
    • Lansing, Michigan, United States
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States
      • Research Site
  • New York
    • Roslyn, New York, United States
      • Research Site
    • Smithtown, New York, United States
      • Research Site
  • North Carolina
    • Raleigh, North Carolina, United States
      • Research Site
  • Ohio
    • Mayfiled Village, Ohio, United States
      • Research Site
  • Pennsylvania
    • Erie, Pennsylvania, United States
      • Research Site
    • Willow Grove, Pennsylvania, United States
      • Research Site
    • Wyomissing, Pennsylvania, United States
      • Research Site
  • Tennessee
    • Jackson, Tennessee, United States
      • Research Site
  • Texas
    • Austin, Texas, United States
      • Research Site
    • San Antonio, Texas, United States
      • Research Site
  • Washington
    • Oklahoma City, Washington, United States
      • Research Site
    • Spokane, Washington, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: R935788

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category	AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event	Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DAS28-CRP Score	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	3 years
HAQ-DI Score	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.	3 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Chris O'Brien, MD, PhD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (ESTIMATE): December 9, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 25, 2014
• Last Update Submitted That Met QC Criteria: May 23, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: RA
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: C-935788-012; D4300C00021