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

NCT00665626 | Completed Phase 2 Results DMC

• 1 other identifier: C-935788-011
• Study Type: interventional
• Target: 219
• Locations: 7 countries
• Sites: 44

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

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology 20 (ACR20) Response at 3 Months

  The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months

  3 months

Secondary Outcomes (30)

• American College of Rheumatology 50 (ACR50) Response at 3 Months

  3 months

• American College of Rheumatology 70 (ACR70) Response at 3 Months

  3 months

• American College of Rheumatology Index of Improvement (ACRn) at 3 Months

  3 months

• Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months

  3 months

• Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months

  3 months

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: Fostamatinib disodium (R935788)

Arm 2

PLACEBO COMPARATOR

Placebo, orally, twice-a-day

Drug: Placebo

Interventions

Fostamatinib disodium (R935788) DRUG

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

Arm 1

Placebo DRUG

Placebo, orally, twice-a-day

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• uncontrolled or poorly controlled hypertension;
• other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);
• recent serious surgery or infectious disease;
• recent history ( of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
• Hepatitis B;
• Hepatitis C;
• interstitial pneumonitis or active pulmonary infection on chest x-ray
• Tuberculosis (TB)
• 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.

Sponsors & Collaborators

• Rigel Pharmaceuticals: lead

Study Sites (44)

Arthritis & Rheumatic Disease Specialties

Aventura, California, 33180, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

San Diego Arthritis & Medical Clinic

San Diego, California, 92108, United States

Location

Department of Rheumatology

Washington D.C., District of Columbia, 20010, United States

Location

RASF-Clinical Research Center

Boca Raton, Florida, 33486, United States

Location

Florida Medical Research Institute

Gainsville, Florida, 32607, United States

Location

Paddock Park Clinical Research

Ocala, Florida, 34474, United States

Location

Lovelace Scientific Resources

Sarasota, Florida, 34233, United States

Location

Intermountain Orthopedics

Boise, Idaho, 83702, United States

Location

Rheumatology Associates, SC

Chicago, Illinois, 60612, United States

Location

Memorial Medical Group Clinical Research Inst

South Bend, Indiana, 46601, United States

Location

Center for Arthritis & Osteoperosis

Elizabethtown, Kentucky, 42701, United States

Location

The Osteoporosis & Clinical Trials Center

Cumberland, Maryland, 21502, United States

Location

The Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, 21740, United States

Location

Fiechtner Research, Inc.

Lansing, Michigan, 48910, United States

Location

Westroads Medical Group

Omaha, Nebraska, 68114, United States

Location

North Shore Long Island Jewich Health System

Lake Success, New York, 11042, United States

Location

Andrew Porges, MD PC

Roslyn, New York, 11576, United States

Location

Rheumatology Associates of Long Island

Smithtown, New York, 11787, United States

Location

Clinical Research Division

Mayfield Village, Ohio, 44143, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Rheumatology Associates

Erie, Pennsylvania, 16508, United States

Location

Clinical Research Center of Reading, LLP

West Reading, Pennsylvania, 34474, United States

Location

Rheumatic Disease Associates

Willow Grove, Pennsylvania, 19090, United States

Location

Austin Rheumatology & Research

Austin, Texas, 78705, United States

Location

Houston Institute for Clinical Research

Houston, Texas, 77074, United States

Location

Arthritis Northwest, PLLC

Spokane, Washington, 99204, United States

Location

ZNA Middelheim

Antwepen, 2020, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHU Liege

Liège, 4000, Belgium

Location

Reumalab S.A.

Medellín, Antioquia, Colombia

Location

Reumatologos del Caribe

Barranquilla, Atlántico, Colombia

Location

CIREEM

Bogota, Cundinamarca, Colombia

Location

Dr. Renato Guzman

Bogota, Cundinamarca, Colombia

Location

Riesgo de Fractura S.A.

Bogota, Cundinamarca, Colombia

Location

Hopital Pellegrin

Bordeaux, 33076, France

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, 60590, Germany

Location

Klinikum Eilbek

Hamburg, 22081, Germany

Location

ClinPharm International GmbH Leipzig

Leipzig, 04103, Germany

Location

Rheumazentrum am Universitatsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97070, Germany

Location

Reumatologia Azienda Ospedaliera Universitaria

Siena, 53100, Italy

Location

Azienda Ospedaliera Santa Maria della Miseri

Udine, 33100, Italy

Location

Instituto de Ginecologia y Reproduccion

Lima, 33, Peru

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Anne-Marie Duliege, MD
• Organization: Rigel

clinicaltrials@rigel.com

650-624-1100

Study Officials

• Daniel B Magilavy, MD

  Rigel Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 1, 2017
• Results First Posted: July 15, 2016

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); DE (5); US (27); PE (1); FR (1); CO (5); IT (2)