Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFα Antagonist Failed in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT02795299
- Lead Sponsor
- Bird Rock Bio, Inc.
- Brief Summary
Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.
- Detailed Description
The trial will include adult patients 18-80 years of age with active disease who have demonstrated an inadequate response to treatment with MTX. Eligible patients will enter a 6-week screening period receiving 15-25 mg MTX QWK (patients will remain on their current dose and route of administration of MTX through the screening period). Patients on a dose of MTX less than 15mg QWK will have their dose of MTX increased to 15mg QWK at the initial screening visit) followed by randomization in a 1:1:1:1 ratio to 1 of 3 doses of gerilimzumab (5, 10, or 20 mg loading dose followed by 2 mg, 5 mg or 10 mg of gerilimzumab Q8W) plus MTX, or placebo plus MTX for 12 weeks of treatment. Gerilimzumab and placebo will be administered as SC injections Q8W; MTX will continue to be administered as by same route of administration (tablets, SC, or IM injection) QWK.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gerilimzumab 5/2 mg/Methotrexate/folate Gerilimzumab • 5 mg gerilimzumab loading dose followed by 2 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Gerilimzumab 10/5mg/Methotrexate/folate Gerilimzumab • 10 mg gerilimzumab loading dose followed by 5 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Gerilimzumab 20/10mg/Methotrexate/folate Gerilimzumab • 20 mg gerilimzumab loading dose followed by 10 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Placebo/Methotrexate/folate Placebo • Placebo every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Gerilimzumab 5/2 mg/Methotrexate/folate Methotrexate • 5 mg gerilimzumab loading dose followed by 2 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Gerilimzumab 5/2 mg/Methotrexate/folate Folic Acid • 5 mg gerilimzumab loading dose followed by 2 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Gerilimzumab 10/5mg/Methotrexate/folate Methotrexate • 10 mg gerilimzumab loading dose followed by 5 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Placebo/Methotrexate/folate Folic Acid • Placebo every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Gerilimzumab 10/5mg/Methotrexate/folate Folic Acid • 10 mg gerilimzumab loading dose followed by 5 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Gerilimzumab 20/10mg/Methotrexate/folate Methotrexate • 20 mg gerilimzumab loading dose followed by 10 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Gerilimzumab 20/10mg/Methotrexate/folate Folic Acid • 20 mg gerilimzumab loading dose followed by 10 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily Placebo/Methotrexate/folate Methotrexate • Placebo every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
- Primary Outcome Measures
Name Time Method Change from baseline in mean DAS28-CRP (Disease Activity Score 28 using the C-Reactive Protein value) to be applied in weeks - 6, -2, -1, 0, 4, 8, 12 and 16
- Secondary Outcome Measures
Name Time Method The proportion of patients meeting the ACR20 (American College of Rheumatology 20%) response criteria at Week 12 to be applied in weeks -6, 0, 4, 8, 12 and 16