A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT02287922. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is: \- 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.
Study identification
- NCT ID
- NCT02287922
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 251 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 74 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2015
- Primary completion
- Jun 30, 2016
- Completion
- Jun 30, 2016
- Last update posted
- Aug 20, 2019
2015 – 2016
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator Site | Birmingham | Alabama | 35216 | — |
| Investigator Site | Hemet | California | 92543 | — |
| Investigator Site | La Palma | California | 90712 | — |
| Investigator site | Los Angeles | California | 90017 | — |
| Investigator Site | Los Angeles | California | 90036 | — |
| Investigator site | Ventura | California | 93003 | — |
| Investigator site | Hialeah | Florida | 33016 | — |
| Investigator Site | Homestead | Florida | 33030 | — |
| Investigator Site | Orlando | Florida | 32804 | — |
| Investigator Site | Stockbridge | Georgia | 30281 | — |
| Investigator site | Overland Park | Kansas | 66209 | — |
| Investigator Site | Worcester | Massachusetts | 01605 | — |
| Investigator Site | Albuquerque | New Mexico | 87102 | — |
| Investigator Site | New York | New York | 10018 | — |
| Investigator Site | Charleston | South Carolina | 29406 | — |
| Investigator Site | Memphis | Tennessee | 38119 | — |
| Investigator Site | Mesquite | Texas | 75150 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 66 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02287922, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02287922 live on ClinicalTrials.gov.