Rheumatoid Arthritis Clinical Trial
— Taski-3Official title:
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic
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.
Status | Completed |
Enrollment | 195 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. - The patient must otherwise be in good health as determined by the Investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. See exclusion criteria for specific exclusions. - 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. 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. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | ZNA Middelheim | Antwepen | |
Belgium | UZ Gent | Gent | |
Belgium | CHU Liege | Liege | |
Colombia | Centro de Reumatologiay Ortopedia | Barranquilla | Atlantico |
Colombia | Reumatologos del Caribe | Barranquilla | Atlantico |
Colombia | CIREEM | Bogota | Cundinamarca |
Colombia | Dr. Renato Guzman | Bogota | Cundinamarca |
Colombia | Riesgo de Fractura S.A. | Bogota | Cundinamarca |
Colombia | SERVIMED | Bucaramanga | Santander |
Colombia | Reumalab S.A. | Medellin | Antioquia |
France | Hopital Pellegrin | Bordeaux Cedex | |
France | CHUG Hopital Sud | Echirolles | |
France | CHR Hopital Roger Salengro | Lille | |
France | Hopital Lapeyronie | Montpellier | |
France | Nouvel Hopital Civil | Strasbourg | |
Germany | Charite-Univeristaets medizin Berlin | Berlin | |
Germany | ClinPharm International GmbH Berlin | Berlin | |
Germany | ClinPharm International GmbH Bochum | Bochum | |
Germany | ClinPharm International GmbH Chemnitz | Chemnitz | |
Germany | ClinPharm International GmbH Dresden | Dresden | |
Germany | Universitatsklinikum Erlangen | Erlangen | |
Germany | ClinPharm International GmbH Frankfurt | Frankfurt | |
Germany | Klinikum der J.W. Goethe Universitaet | Frankfurt | |
Germany | Klinikum Eilbek | Hamburg | |
Germany | ClinPharm International GmbH Leipzig | Leipzig | |
Germany | Rheumazentrum am Universitatsklinikum Leipzig | Leipzig | |
Germany | ClinPharm International GmbH Potsdam | Potsdam | |
Germany | Ev. Fachkrankenhaus Ratingen | Ratingen | |
Germany | Universitatsklinikum Wurzburg | Wurzburg | |
Italy | Servizio di Reumatologia Policlinico di Modena | Modena | |
Italy | Reumatologia Azienda Ospedaliera Universitaria | Siena | |
Italy | Azienda Ospedaliera Santa Maria della Miseri | Udine | |
Peru | Hospital Nacional Alberto Sabogal Sologuren E | Callao | |
Peru | Rheumatology Clinica San Felipe | Jesus Maria | Lima |
Peru | Clinica Ricardo Palma | Lima | |
Peru | Instituto de Ginecologia y Reproduccion | Lima | |
United States | Arthritis Clinic of Northern Virginia, P.C. | Arlington | Virginia |
United States | Austin Rheumatology & Research | Austin | Texas |
United States | Arthritis & Rheumatic Disease Specialties | Aventura | California |
United States | RASF-Clinical Research Center | Boca Raton | Florida |
United States | Intermountain Orthopedics | Boise | Idaho |
United States | Rheumatology Associates | Charleston | South Carolina |
United States | Rheumatology Associates, SC | Chicago | Illinois |
United States | Arthritis Associates of Colorado Springs | Colorado Springs | Colorado |
United States | The Osteoporosis & Clinical Trials Center | Cumberland | Maryland |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | Center for Arthritis & Osteoperosis | Elizabethtown | Kentucky |
United States | Rheumatology Associates | Erie | Pennsylvania |
United States | Florida Medical Research Institute | Gainsville | Florida |
United States | Holzer Clinic | Gallipolis | Ohio |
United States | The Osteoporosis & Clinical Trials Center | Hagerstown | Maryland |
United States | Arthritis & Osteoporosis Center, PC | Hamden | Connecticut |
United States | Accurate Clinical Research | Houston | Texas |
United States | Houston Institute for Clinical Research | Houston | Texas |
United States | Rheumatic Disease Clinical Research | Houston | Texas |
United States | North Shore Long Island Jewich Health System | Lake Success | New York |
United States | Fiechtner Research, Inc. | Lansing | Michigan |
United States | Clinical Research Division | Mayfield Village | Ohio |
United States | Paddock Park Clinical Research | Ocala | Florida |
United States | Health Research of Oklahoma | Oklahoma City | Oklahoma |
United States | Westroads Medical Group | Omaha | Nebraska |
United States | Jeffrey Poiley | Orlando | Florida |
United States | Desert Medical Advances | Palm Desert | California |
United States | Stanford University School of Medicine | Palo Alto | California |
United States | North Carolina Arthritis & Allergy Care Cente | Raleigh | North Carolina |
United States | Andrew Porges, MD PC | Roslyn | New York |
United States | University of California at Davis Medical Center | Sacramento | California |
United States | San Diego Arthritis & Medical Clinic | San Diego | California |
United States | Lovelace Scientific Resources | Sarasota | Florida |
United States | Rheumatology Associates of Long Island | Smithtown | New York |
United States | Memorial Medical Group Clinical Research Inst | South Bend | Indiana |
United States | Arthritis Northwest, PLLC | Spokane | Washington |
United States | Tampa Medical Group | Tampa | Florida |
United States | Department of Rheumatology | Washington | District of Columbia |
United States | Clinical Research Center of Reading, LLP | West Reading | Pennsylvania |
United States | Rheumatic Disease Associates | Willow Grove | Pennsylvania |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Rigel Pharmaceuticals |
United States, Belgium, Colombia, France, Germany, Italy, Peru,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this study is to assess the efficacy of R788 100 mg PO bid compared with placebo, as determined by ACR20 responder rates at Month 3. | Month 3 | No | |
Secondary | To assess the response rate of R788 100 mg PO bid as determined by ACR50, ACR70, ACRn, DAS28-CRP, and DAS28-ESR at Month 3 | Month 3 | No | |
Secondary | To assess the rapidity of onset of clinical effect of R788 100 mg PO bid compared with placebo as determined by ACR20 response rates at Weeks 1 and 2 | Week 1 and Week 2 | No | |
Secondary | To assess the radiologic response of R788 100 mg PO bid compared with placebo as determined by Magnetic Resonance Imaging (MRI) using the modified RAMRIS scoring system of hands and wrists at baseline and Month 3 | Month 3 | No | |
Secondary | To assess and compare the safety profiles of R788 100 mg PO bid dose with placebo for effects on liver function tests, clinically significant reduction in peripheral neutrophil counts, G-I side effects and other adverse effects as they may appear. | Study | Yes |
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