Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3)

NCT ID: NCT00665626

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Fostamatinib disodium (R935788) 100 mg tablet, orally, twice-a-day

Group Type: EXPERIMENTAL

Fostamatinib disodium (R935788)

Intervention Type: DRUG

R935788 100 mg tablet, orally, twice-a-day

Arm 2

Placebo, orally, twice-a-day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, orally, twice-a-day

Interventions

Fostamatinib disodium (R935788)

R935788 100 mg tablet, orally, twice-a-day

Intervention Type: DRUG

Placebo

Placebo, orally, twice-a-day

Intervention Type: DRUG

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.
• Males and females, 18 years of age or older, with active RA for at least 12 months prior to Day 1 dosing
• Are currently receiving or previously had received a biologic therapy with an inhibitor of TNF, rituximab, abatacept, or anakinra at an approved labeled dose for ≥3 months prior to Day 1 dosing and are designated as biologic therapy failures for lack of efficacy, safety, or tolerability.
• Patients may receive stable doses of methotrexate (MTX), azathioprine (not in combination with MTX), leflunomide (not in combination with MTX), sulfasalazine, chloroquine, hydroxychloroquine, gold, NSAIDs (including COX2 inhibitors), minocycline, or doxycycline. The dose must have been stable for at least 30 days prior to Day 1 dosing and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements. Patients who are taking MTX must have been receiving weekly MTX doses (7.5-25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing. Patients who are receiving MTX must also be receiving folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing.
• 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 urine pregnancy test at the time of randomization and at each laboratory determination.

Exclusion Criteria

• In the Investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol.

• 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. uncontrolled or poorly controlled hypertension;

2. other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);

3. recent serious surgery or infectious disease;

4. recent history ( of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;

5. Hepatitis B;

6. Hepatitis C;

7. interstitial pneumonitis or active pulmonary infection on chest x-ray

8. Tuberculosis (TB)

9. known laboratory abnormalities

• 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 has been treated previously treated with R788 under a different protocol.
• The patient has a pacemaker, aneurysm clip or other contraindication to MRI.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigel Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel B Magilavy, MD

Role: STUDY_DIRECTOR

Rigel Pharmaceuticals

Locations

Arthritis & Rheumatic Disease Specialties

Aventura, California, United States

Desert Medical Advances

Palm Desert, California, United States

San Diego Arthritis & Medical Clinic

San Diego, California, United States

Department of Rheumatology

Washington D.C., District of Columbia, United States

RASF-Clinical Research Center

Boca Raton, Florida, United States

Florida Medical Research Institute

Gainsville, Florida, United States

Paddock Park Clinical Research

Ocala, Florida, United States

Lovelace Scientific Resources

Sarasota, Florida, United States

Intermountain Orthopedics

Boise, Idaho, United States

Rheumatology Associates, SC

Chicago, Illinois, United States

Memorial Medical Group Clinical Research Inst

South Bend, Indiana, United States

Center for Arthritis & Osteoperosis

Elizabethtown, Kentucky, United States

The Osteoporosis & Clinical Trials Center

Cumberland, Maryland, United States

The Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, United States

Fiechtner Research, Inc.

Lansing, Michigan, United States

Westroads Medical Group

Omaha, Nebraska, United States

North Shore Long Island Jewich Health System

Lake Success, New York, United States

Andrew Porges, MD PC

Roslyn, New York, United States

Rheumatology Associates of Long Island

Smithtown, New York, United States

Clinical Research Division

Mayfield Village, Ohio, United States

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

Rheumatology Associates

Erie, Pennsylvania, United States

Clinical Research Center of Reading, LLP

West Reading, Pennsylvania, United States

Rheumatic Disease Associates

Willow Grove, Pennsylvania, United States

Austin Rheumatology & Research

Austin, Texas, United States

Houston Institute for Clinical Research

Houston, Texas, United States

Arthritis Northwest, PLLC

Spokane, Washington, United States

ZNA Middelheim

Antwepen, , Belgium

UZ Gent

Ghent, , Belgium

CHU Liege

Liège, , Belgium

Reumalab S.A.

Medellín, Antioquia, Colombia

Reumatologos del Caribe

Barranquilla, Atlántico, Colombia

CIREEM

Bogota, Cundinamarca, Colombia

Dr. Renato Guzman

Bogota, Cundinamarca, Colombia

Riesgo de Fractura S.A.

Bogota, Cundinamarca, Colombia

Hopital Pellegrin

Bordeaux, , France

Klinikum der J.W. Goethe Universitaet

Frankfurt, , Germany

Klinikum Eilbek

Hamburg, , Germany

ClinPharm International GmbH Leipzig

Leipzig, , Germany

Rheumazentrum am Universitatsklinikum Leipzig

Leipzig, , Germany

Universitatsklinikum Wurzburg

Würzburg, , Germany

Reumatologia Azienda Ospedaliera Universitaria

Siena, , Italy

Azienda Ospedaliera Santa Maria della Miseri

Udine, , Italy

Instituto de Ginecologia y Reproduccion

Lima, , Peru

Countries

United States; Belgium; Colombia; France; Germany; Italy; Peru

Other Identifiers

C-935788-011

Identifier Type: -

Identifier Source: org_study_id