A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT02309359. 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, 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02309359
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 345 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
- Jan 2015 (Type not available)
- Primary completion
- Aug 2016 (Actual)
- Completion
- Aug 2016 (Actual)
- Last update posted
- Aug 21, 2019
2015 – 2016
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 21
| 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 Sites | Hialeah | Florida | 33016 | — |
| Investigator Site | Homestead | Florida | 33030 | — |
| Investigator Site | Miami | Florida | 33135 | — |
| Investigator Site | Miami Lakes | Florida | 33016 | — |
| Investigator Site | Orlando | Florida | 32804 | — |
| Investigator Site | Stockbridge | Georgia | 30281 | — |
| Investigator Site | Overland Park | Kansas | 66209 | — |
| Investigator Site | Monroe | Louisiana | 71203 | — |
| Investigator Site | Worcester | Massachusetts | 01605 | — |
| Investigator Site | Albuquerque | New Mexico | 87102 | — |
| Investigator Site | Brooklyn | New York | 11201 | — |
| Investigator Site | New York | New York | 10018 | — |
| Investigator Sie | Charleston | South Carolina | 29406 | — |
| Investigator Site | Myrtle Beach | South Carolina | 29572 | — |
| 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 72 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02309359, 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 21, 2019 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02309359 live on ClinicalTrials.gov.