Rheumatoid Arthritis Clinical Trial
— Taski-2Official title:
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.
Status | Completed |
Enrollment | 420 |
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 6 months prior to Day 1 dosing. - Patients must have been receiving weekly methotrexate 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 must be receiving a 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 (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease; 4. recent history (past 5 years prior to Day 1 dosing) 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): the TB skin test should be negative. 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. |
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 |
---|---|---|---|
Bulgaria | MMA HAT Pleven | Pleven | |
Bulgaria | MHAT "Kaspela" | Plovdiv | PLO |
Bulgaria | MHAT Ruse | Ruse | |
Bulgaria | DCC "Sv. Anna" Sofia | Sofia | |
Bulgaria | MHAT "Sv. Ivan Rilski" | Sofia | |
Bulgaria | MMA HAT Sofia | Sofia | Gsof |
Bulgaria | MNTranspH "Tsar Boris Treti" | Sofia | Gsof |
Bulgaria | Tokuda Hospital Sofia | Sofia | |
Bulgaria | MHAT " Sveta Marina" | Varna | |
Colombia | Centro de Reumatologia y Ortopedia | Barranquilla | Atlántico |
Colombia | Reumatologos del Caribe | Barranquilla | Atlántico |
Colombia | CIREEM | Bogota | Cundinamarca |
Colombia | Fundación Instituto de Reumatología | Bogota | Cundinamarca |
Colombia | Riesgo de Fractura S.A | Bogota | Cundinamarca |
Colombia | Private Office | Bogotá | Cundinamarca |
Colombia | Centro Medico Carlos Ardila Lulle | Bucaramanga | Santander |
Colombia | SERVIMED | Bucaramanga | Santander |
Colombia | Unidad Medica Torre Plaza | Medellín | Antioquia |
Israel | The Chaim Sheba Medical Center | Ramat Gan | |
Mexico | Centenario Hospital Miguel Hidalgo | Aguascalientes | |
Mexico | Christus Muguerza del Parque | Chihuahua | |
Mexico | Hospital Inovamed , Torre Médica | Cuernavaca | Morelos |
Mexico | Hospital Civil de Guadalajara "Fray Antonio A | Guadalajara | Jalisco |
Mexico | Instituto Jalisciense de Investigación Clínica | Guadalajara | Jalisco |
Mexico | Hospital Aranda de la Parra | Leon | Guanajuato |
Mexico | Arké Estudios Clínicos S.A de C.V | Mexico | D.f. |
Mexico | Centro Médico DALINDE | Mexico | Distrito Federal |
Mexico | Clínica para el Diagnostico y Tratamiento de | Mexico | D.f. |
Mexico | Hospital Ángeles Metropolitano | Mexico | D.f. |
Mexico | Hospital General de México | Mexico | D.f. |
Mexico | Star Médica | Morelia | Michoacán |
Poland | NZOZ Centrum Medyczne Artur Racewicz | Bialystok | |
Poland | SPZOZ Szpital Wojewodzkiim J. Biziela | Bydgoszcz | |
Poland | Szpit. Spec.Nr 1, Odz. Reumatol. i Reh. | Bytom | |
Poland | Wojewodzki Szpital Zespolony Oddzial Reumatol | Elblag | |
Poland | Mazowieckie Centrum Badan Klinicznych | Grodzisk Mazowiecki | |
Poland | Krakowskie Centrum Medyczne NZOZ | Krakow | |
Poland | Malopolskie Centrum Medyczne SC | Krakow | |
Poland | NZOZ Reumed | Lublin | |
Poland | SCD-Med. Bamberski Dwor Sp. z o.o. | Poznan | |
Poland | NZOZ "Nasz Lekarz" | Torun | |
Poland | WIM Klinika Chorob Wewnetrznych i Reumatologi | Warsaw | |
Poland | Centrum Medyczne Osteomed | Warszawa | |
Poland | ASK Klinika Reumatologii i Chor. Wewn. | Wroclaw | |
Poland | Synexus SCM | Wroclaw | |
Poland | ZOZ w Zyradowie Oddzial Reumatologii | Zyradow | |
Romania | CMI "Cristei R. Dorica" | Braila | |
Romania | Spitalul Clinic "Sf. Maria" Med Int si Reumat | Bucuresti | Sector 1 |
Romania | Spitalul de Urgenta al MAI Dr. D. Gerota | Bucuresti | |
Romania | Spitalul Clinic Judetean de Urgenta Cluj Reum | Cluj-Napoca | Cluj |
Romania | Spitalul Judetean "Dr. Fogolyan Kristol" | Sf. Gheorghe | |
Romania | Spitalul Clinic Judetean Sibiu | Sibiu | |
United States | Austin Rheumatology & Research | Austin | Texas |
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 | Center for Arthritis & Osteoporosis | 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 | Divison of Rheumatology Allergy and Immunology | La Jolla | California |
United States | Fiechtner Research, Inc. | Lansing | Michigan |
United States | Paddock Park Clinical Research | Ocala | Florida |
United States | Health Research of Oklahoma | Oklahoma | Oklahoma |
United States | Westroads Medical Group | Omaha | Nebraska |
United States | Jeffrey Poiley, MD | Orlando | Florida |
United States | Desert Medical Advances | Palm Desert | California |
United States | North Carolina Arthritis & Allergy Care Center | Raleigh | North Carolina |
United States | Rockford Health Physician | Rockford | Illinois |
United States | University of California at Davis Medical Center | Sacramento | California |
United States | Arthritis Center of South Texas | San Antonio | Texas |
United States | Lovelace Scientific Resources | Sarasota | Florida |
United States | Memorial Medical Group Clinical Research Inst | South Bend | Indiana |
United States | Arthritis Northwest, PLLC | Spokane | Washington |
United States | Cynthia Morgan | Washington | District of Columbia |
United States | Clinical Research Center of Reading, LLP | West Reading | Pennsylvania |
United States | Rheumatic Disease Associates | Willow Grove | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Bulgaria, Colombia, Israel, Mexico, Poland, Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | confirm the efficacy of R788 100 mg PO bid as determined by ACR20 responder rates at 6 months. | 6 months | No | |
Secondary | compare response rates for R788 100 mg PO bid and R788 150 mg PO qd as determined by ACR20, ACR50, ACR70, ACRn, DAS28-CRP and DAS28-ESR response rates over 6 months | 6 months | No | |
Secondary | To assess the rapidity of onset of clinical effect among the R788 100 mg PO bid, R788 150 mg PO qd, and placebo groups as determined by ACR20 response rates at Weeks 1 and 2 | Week 1 and Week 2 | No | |
Secondary | To compare changes for R788 100 mg PO bid and R788 150 mg PO qd in the FACIT-fatigue and SF-36 from baseline to 6 months | 6 month | No | |
Secondary | To assess and compare the safety profiles for R788 100 mg bid and R788 150 mg qd compared with placebo for effects on liver function tests, clinically significant reductions in peripheral neutrophil counts, G-I side effects and other adverse effect | Study | Yes |
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