A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
2 other identifiers
interventional
345
14 countries
94
Brief Summary
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Jan 2015
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2014
CompletedFirst Posted
Study publicly available on registry
December 5, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
August 21, 2019
CompletedAugust 21, 2019
August 1, 2019
1.6 years
November 27, 2014
June 12, 2019
August 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12
ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non responders.
Week 12
Secondary Outcomes (23)
Number and Percentage of Subjects With ACR20 Response at Week 24
24 weeks
Number and Percentage of Subjects With ACR50 Response at Weeks 12 and 24
24 weeks
Number and Percentage of Subjects With ACR70 Response at Weeks 12 and 24
24 weeks
Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score 28 (DAS28) Using C-reactive Protein (CRP) at Weeks 12 and 24
24 weeks
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Weeks 12 and 24
24 weeks
- +18 more secondary outcomes
Study Arms (5)
Placebo q2w + MTX
PLACEBO COMPARATORPlacebo 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 75 mg q4w + MTX
EXPERIMENTALALX-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 150 mg q4w + MTX
EXPERIMENTALALX-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 150 mg q2w + MTX
EXPERIMENTALALX-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 225 mg q2w + MTX
EXPERIMENTALALX-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.
Interventions
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
Eligibility Criteria
You may qualify if:
- Diagnosis of RA for at least 6 months prior to screening, and American College of Rheumatology (ACR) functional class I-III
- Subjects treated with and tolerating MTX
- Active RA
- Others as defined in the protocol
You may not qualify if:
- Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Investigator Site
Birmingham, Alabama, 35216, United States
Investigator Site
Hemet, California, 92543, United States
Investigator Site
La Palma, California, 90712, United States
Investigator Site
Los Angeles, California, 90017, United States
Investigator site
Los Angeles, California, 90036, United States
Investigator Site
Ventura, California, 93003, United States
Investigator Sites
Hialeah, Florida, 33016, United States
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Homestead, Florida, 33030, United States
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Miami, Florida, 33135, United States
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Miami Lakes, Florida, 33016, United States
Investigator Site
Orlando, Florida, 32804, United States
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Stockbridge, Georgia, 30281, United States
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Overland Park, Kansas, 66209, United States
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Monroe, Louisiana, 71203, United States
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Worcester, Massachusetts, 01605, United States
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Albuquerque, New Mexico, 87102, United States
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Brooklyn, New York, 11201, United States
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New York, New York, 10018, United States
Investigator Sie
Charleston, South Carolina, 29406, United States
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Myrtle Beach, South Carolina, 29572, United States
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Memphis, Tennessee, 38119, United States
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Mesquite, Texas, 75150, United States
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Liège, 4000, Belgium
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Pleven, 5800, Bulgaria
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Plovdiv, 4001, Bulgaria
Investigator Site 1
Rousse, 7000, Bulgaria
Investigator Site 2
Rousse, 7000, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1612, Bulgaria
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Varna, 9000, Bulgaria
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Brno, 60200, Czechia
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Olomouc, 77900, Czechia
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Prague, 12850, Czechia
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Prague, Czechia
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Zlín, 76001, Czechia
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Tbilisi, 0102, Georgia
Investigator Site 1
Tbilisi, 0159, Georgia
Investigator Site 2
Tbilisi, 0159, Georgia
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Tbilisi, 0160, Georgia
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Tbilisi, 0179, Georgia
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Bad Nauheim, 61231, Germany
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Berlin, 10117, Germany
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Berlin, Germany
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Cologne, 50973, Germany
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Frankfurt, Germany
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Hamburg, 22081, Germany
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Baja, 6500, Hungary
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Balatonfüred, 8230, Hungary
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Békéscsaba, 5600, Hungary
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Budapest, 1038, Hungary
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Gyula, 5700, Hungary
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Székesfehérvar, 8000, Hungary
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Szikszó, 3800, Hungary
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Veszprém, 8200, Hungary
Investigator Site
Culiacán, 80000, Mexico
Investigator Site
León, 37000, Mexico
Investigator Site 1
Mexico City, 03100, Mexico
Investigator Site 2
Mexico City, 06700, Mexico
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Mérida, 97070, Mexico
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Monclova, 25714, Mexico
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Monterrey, 64000, Mexico
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Monterrey, 64460, Mexico
Investigator Site
Chisinau, 2025, Moldova
Investigator Site 1
Skopje, 1000, North Macedonia
Investigator Site 2
Skopje, 1000, North Macedonia
Investigator Site
Bydgoszcz, 85168, Poland
Investigator Site
Elblag, 82300, Poland
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Elblag, Poland
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Gdynia, 81338, Poland
Investigator Site
Grodzisk Mazowiecki, 05825, Poland
Investigator Site
Katowice, 40954, Poland
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Lublin, 20582, Poland
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Poznan, 60773, Poland
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Sochaczew, 96500, Poland
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Torun, 87100, Poland
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Warsaw, 02653, Poland
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Brăila, 800578, Romania
Investigator Site
Bucharest, 010976, Romania
Investigator Site
Bucharest, 020475, Romania
Investigator Site
Oradea, 410028, Romania
Investigator Site
Târgu Mureş, 540142, Romania
Investigator Site
Timișoara, 300057, Romania
Investigator Site 1
Belgrade, 11000, Serbia
Investigator Site 2
Belgrade, 11000, Serbia
Investigator Site 3
Belgrade, 11000, Serbia
Investigator Site
Niška Banja, 18205, Serbia
Investigator Site
Novi Sad, 21112, Serbia
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Madrid, 28007, Spain
Investigator Site
Madrid, 28041, Spain
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Salamanca, 37007, Spain
Investigator Site
Santiago de Compostela, 15702, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
None reported
Results Point of Contact
- Title
- Medical Monitor
- Organization
- Ablynx NV
Study Officials
- STUDY DIRECTOR
Ablynx Clinical Department
Ablynx, a Sanofi company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2014
First Posted
December 5, 2014
Study Start
January 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 21, 2019
Results First Posted
August 21, 2019
Record last verified: 2019-08