Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT02919761. 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 Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR. Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks. A single participant might be involved in the trial for as many as 32 weeks.
Study identification
- NCT ID
- NCT02919761
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 259 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Nov 7, 2016 (Actual)
- Primary completion
- Oct 17, 2018 (Actual)
- Completion
- Feb 13, 2019 (Actual)
- Last update posted
- Mar 31, 2020
2016 – 2019
United States locations
- U.S. sites
- 30
- U.S. states
- 10
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| East Bay Rheumatology Medical Group | San Leandro | California | 94578 | — |
| Inland Rheumatology Clinical Trials | Upland | California | 91786 | — |
| Orthopedic Research Institute | Boynton Beach | Florida | 33472 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Southeastern Integrated Medical, PL, d/b/a Florida Medical Research | Gainesville | Florida | 32607 | — |
| Indago Research and Health Center | Hialeah | Florida | 33012 | — |
| Homestead Associates in Research | Homestead | Florida | 33032 | — |
| Pharmax Research Clinic | Miami | Florida | 33126 | — |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | — |
| San Marcus Research Clinic | Miami Lakes | Florida | 33015 | — |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | — |
| Omega Research Consultants-DeBary | Orlando | Florida | 32810 | — |
| Millennium Research | Ormond Beach | Florida | 32174 | — |
| Clinical Research of West Florida | Tampa | Florida | 33603 | — |
| Arthritis & Rheumatology of Georgia, PC | Atlanta | Georgia | 30342 | — |
| Arthritis Research and Treatment Center | Stockbridge | Georgia | 30281 | — |
| Arthritis and Diabetes Clinic, Inc. | Monroe | Louisiana | 71203 | — |
| June DO, PC | Lansing | Michigan | 48910 | — |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | — |
| DJL Clinical Research | Charlotte | North Carolina | 28210 | — |
| Columbia Arthritis Center | Columbia | South Carolina | 29204 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Ramesh C. Gupta, MD | Memphis | Tennessee | 38119 | — |
| Northwest Med Care | Cypress | Texas | 77429 | — |
| Rheumatic Disease Clinical Research Center | Houston | Texas | 77004 | — |
| Accurate Clinical Research | Houston | Texas | 77034 | — |
| Laila Hassan, MD, PA | Houston | Texas | 77089 | — |
| Pioneer Research Solutions | Houston | Texas | 77099 | — |
| Southwest Rheumatology Research | Mesquite | Texas | 75150 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02919761, 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 Mar 31, 2020 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02919761 live on ClinicalTrials.gov.