A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
NCT ID: NCT02287922
Last Updated: 2019-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
251 participants
INTERVENTIONAL
2015-03-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
\- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).
The secondary objectives of this study are:
* To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development.
* To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
NCT02309359
Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients
NCT01284569
An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis
NCT02518620
ALX-0061 Phase I Bioavailability Study in Healthy Volunteers
NCT02101073
A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
NCT00785928
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ALX-0061 150 mg q4w
ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
ALX-0061
Placebo
ALX-0061 150 mg q2w
ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
ALX-0061
Placebo
ALX-0061 225 mg q2w
ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit.
ALX-0061
TCZ 162 mg q1w or q2w
Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen).
Tocilizumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ALX-0061
Placebo
Tocilizumab
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
* Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
* Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
* Others as defined in the protocol
Exclusion Criteria
* Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase \[JAK\]-inhibitors) 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 (including JAK inhibitors), 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Ablynx, a Sanofi company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor, MD
Role: STUDY_DIRECTOR
Ablynx, a Sanofi company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 site
Hialeah, Florida, United States
Investigator Site
Homestead, Florida, United States
Investigator Site
Orlando, Florida, United States
Investigator Site
Stockbridge, Georgia, United States
Investigator site
Overland Park, Kansas, United States
Investigator Site
Worcester, Massachusetts, United States
Investigator Site
Albuquerque, New Mexico, United States
Investigator Site
New York, New York, United States
Investigator Site
Charleston, South Carolina, United States
Investigator Site
Memphis, Tennessee, United States
Investigator Site
Mesquite, Texas, United States
Investigator Site
Brussels, , Belgium
Investigator Site
Ghent, , Belgium
Investigator Site
Liège, , Belgium
Investigator Site
Burgas, , Bulgaria
Investigator Site
Pleven, , Bulgaria
Investigator Site 1
Plovdiv, , Bulgaria
Investigator Site 2
Plovdiv, , Bulgaria
Investigator Site 1
Rousse, , Bulgaria
Investigator Site 2
Rousse, , Bulgaria
Investigator Site
Sofia, , Bulgaria
Investigator Site
Brno, , Czechia
Investigator Site
Olomouc, , Czechia
Investigator Site
Ostrava, , Czechia
Investigator Site 1
Prague, , Czechia
Investigator Site 2
Prague, , Czechia
Investigator Site
Zlín, , Czechia
Investigator Site
Tbilisi, , Georgia
Investigator Site 1
Tbilisi, , Georgia
Investigator Site 2
Tbilisi, , Georgia
Investigator Site
Tbilisi, , Georgia
Investigator Site
Tbilisi, , Georgia
Investigator Site
Berlin, , Germany
Investigator Site
Frankfurt, , Germany
Investigator Site
Hamburg, , Germany
Investigator Site
Baja, , Hungary
Investigator Site
Budapest, , Hungary
Investigator Site
Esztergom, , Hungary
Investigator site
Gyula, , Hungary
Investigator Site
Székesfehérvar, , Hungary
Investigator Site
Szikszó, , Hungary
Investigator Site
Szombathely, , Hungary
Investigator Site
Veszprém, , Hungary
Investigator Site
Culiacán, , Mexico
Investigator Site
León, , Mexico
Investigator Site 1
Mexico City, , Mexico
Investigator Site 2
Mexico City, , Mexico
Investigator Site
Mexico City, , Mexico
Investigator Site 1
Monterrey, , Mexico
Investigator Site 2
Monterrey, , Mexico
Investigator Site
Chisinau, , Moldova
Investigator Site
Chisinau, , Moldova
Investigator Site 1
Skopje, , North Macedonia
Investigator Site 2
Skopje, , North Macedonia
Investigator Site
Bydgoszcz, , Poland
Investigator Site 2
Elblag, , Poland
Investigator Site
Elblag, , Poland
Investigator Site
Gdynia, , Poland
Investigator Site
Grodzisk Mazowiecki, , Poland
Investigator Site
Lublin, , Poland
Investigator SIte
Poznan, , Poland
Investigator Site
Sochaczew, , Poland
Investigator Site
Torun, , Poland
Investigator Site
Warsaw, , Poland
Investigator Site
Bucharest, , Romania
Investigator Site
Oradea, , 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
Córdoba, , Spain
Investigator Site
Madrid, , Spain
Investigator Site
Santander, , Spain
Investigator Site 2
Santander, , Spain
Investigator Site 1
Santiago de Compostela, , Spain
Investigator Site 2
Santiago de Compostela, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-003012-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALX0061-C202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.