A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
NCT ID: NCT02309359
Last Updated: 2019-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
345 participants
INTERVENTIONAL
2015-01-31
2016-08-31
Brief Summary
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To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo q2w + MTX
Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
Placebo
Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
ALX-0061 75 mg q4w + MTX
ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
ALX-0061
Placebo
Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
ALX-0061 150 mg q4w + MTX
ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
ALX-0061
Placebo
Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
ALX-0061 150 mg q2w + MTX
ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
ALX-0061
Placebo
Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
ALX-0061 225 mg q2w + MTX
ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.
The last study drug administration was at the Week 22 visit.
ALX-0061
Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
Interventions
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ALX-0061
Placebo
Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
Eligibility Criteria
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Inclusion Criteria
* Subjects treated with and tolerating MTX
* Active RA
* Others as defined in the protocol
Exclusion Criteria
* Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening.
* Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs, for RA.
* Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
* Others as defined in the protocol
18 Years
74 Years
ALL
No
Sponsors
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Ablynx, a Sanofi company
INDUSTRY
Responsible Party
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Principal Investigators
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Ablynx Clinical Department
Role: STUDY_DIRECTOR
Ablynx, a Sanofi company
Locations
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Investigator Site
Birmingham, Alabama, United States
Investigator Site
Hemet, California, United States
Investigator Site
La Palma, California, United States
Investigator Site
Los Angeles, California, United States
Investigator site
Los Angeles, California, United States
Investigator Site
Ventura, California, United States
Investigator Sites
Hialeah, Florida, United States
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Homestead, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Orlando, Florida, United States
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Stockbridge, Georgia, United States
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Overland Park, Kansas, United States
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Monroe, Louisiana, United States
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Worcester, Massachusetts, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New York, New York, United States
Investigator Sie
Charleston, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Memphis, Tennessee, United States
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Mesquite, Texas, United States
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Liège, , Belgium
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
Investigator Site 1
Rousse, , Bulgaria
Investigator Site 2
Rousse, , Bulgaria
Investigator Site
Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Brno, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Zlín, , Czechia
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Tbilisi, , Georgia
Investigator Site 1
Tbilisi, , Georgia
Investigator Site 2
Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Bad Nauheim, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Baja, , Hungary
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Balatonfüred, , Hungary
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Gyula, , Hungary
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Székesfehérvar, , Hungary
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Szikszó, , Hungary
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Veszprém, , Hungary
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Culiacán, , Mexico
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León, , Mexico
Investigator Site 1
Mexico City, , Mexico
Investigator Site 2
Mexico City, , Mexico
Investigator Site
Mérida, , Mexico
Investigator Site
Monclova, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
Investigator Site
Chisinau, , Moldova
Investigator Site 1
Skopje, , North Macedonia
Investigator Site 2
Skopje, , North Macedonia
Investigator Site
Bydgoszcz, , Poland
Investigator Site
Elblag, , Poland
Investigator Site
Elblag, , Poland
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Gdynia, , Poland
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Grodzisk Mazowiecki, , Poland
Investigator Site
Katowice, , Poland
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Lublin, , Poland
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Poznan, , Poland
Investigator Site
Sochaczew, , Poland
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Torun, , Poland
Investigator Site
Warsaw, , Poland
Investigator Site
Brăila, , Romania
Investigator Site
Bucharest, , Romania
Investigator Site
Bucharest, , Romania
Investigator Site
Oradea, , Romania
Investigator Site
Târgu Mureş, , Romania
Investigator Site
Timișoara, , Romania
Investigator Site 1
Belgrade, , Serbia
Investigator Site 2
Belgrade, , Serbia
Investigator Site 3
Belgrade, , Serbia
Investigator Site
Niška Banja, , Serbia
Investigator Site
Novi Sad, , Serbia
Investigator Site
Madrid, , Spain
Investigator Site
Madrid, , Spain
Investigator Site
Salamanca, , Spain
Investigator Site
Santiago de Compostela, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-003033-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALX0061-C201
Identifier Type: -
Identifier Source: org_study_id
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