Rheumatoid Arthritis Clinical Trial
Official title:
A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha
NCT number | NCT00913432 |
Other study ID # | AB06010 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2007 |
Est. completion date | September 2010 |
Verified date | December 2018 |
Source | AB Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2010 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA. 2. ACR functional class I-III 3. Have active RA 4. Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha Exclusion Criteria: 1. Patient had a major surgery within 2 weeks prior to study entry. 2. Life expectancy < 6 months. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AB Science |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | American College of Rheumatology Score 50 | week 12 | ||
Secondary | DAS28 | week 4, 8 and 12 |
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