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| Sponsor: | Rigel Pharmaceuticals |
|---|---|
| Information provided by: | Rigel Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00665925 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Fostamatinib disodium (R935788) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official 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 |
| Estimated Enrollment: | 420 |
| Study Start Date: | May 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
R788, 100 mg tablet, orally, twice-a-day
|
Drug: Fostamatinib disodium (R935788)
100 mg tablet, orally, twice-a-day 150 mg tablet, orally, once-a-day
|
|
2: Experimental
R788, 150 mg tablet, orally, once a day
|
Drug: Fostamatinib disodium (R935788)
100 mg tablet, orally, twice-a-day 150 mg tablet, orally, once-a-day
|
|
3: Placebo Comparator
Placebo, orally, either once a day, or twice a day
|
Drug: Fostamatinib disodium (R935788)
100 mg tablet, orally, twice-a-day 150 mg tablet, orally, once-a-day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
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:
Contacts and Locations
Show 79 Study Locations| Study Director: | Daniel B Magilavy, MD | Rigel Pharmaceuticals |
More Information
| Responsible Party: | Rigel Pharmaceuticals, Inc ( Daniel B. Magilavy, MD/Vice President, Clinical Development ) |
| Study ID Numbers: | C-935788-010 |
| Study First Received: | April 22, 2008 |
| Last Updated: | September 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00665925 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Argentina: Ministry of Health [Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT)]; Argentina: Independient Ethics Committee for Clinical Pharmacology Assays (Comite Independiente de Etica para Ensayos en Farmacologia clinica); Argentina: Ethics Committee (Ethic Committee of each institution); Brazil: Ethics Committee (Ethic Committee of each institution); Brazil: Ministry of Health (Conselho Nacional de Saude, CNS); Brazil: National Committee of Ethics in Research (Comissao Nacional de Etica em Pesquisa, CONEP); Brazil: National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA); Bulgaria: Bulgarian Drug Agency; Colombia: Ministry of Health (INVIMA: Instituto Nacional de Vigilancia de Medicamentos y Alimentos); Colombia: Ethics Committee (Ethic Committee of each institution); Hungary: National Institute of Pharmacy; Israel: Ethics Commission; Israel: Israeli Health Ministry Pharmaceutical Administration; Mexico: Ethics Committee (each site submits to their local EC).; Mexico: Federal Commission for Protection Against Health Risks; Mexico: Federal Commission for Sanitary Risks Protection; Mexico: Ministry of Health (Secretaria de Salud, SSA); Peru: Ethics Committee (19 registered IECs, the one used for this study is Comite de Etica de la Universidad de San Martin de Porres, CEUSMP).; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs (Dirección general de medicamentos, insumos y drogas, DIGEMID); Peru: Ministry of Health (Instituto Nacional de Salud, INS); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency |
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Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |