Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT02640612. 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
Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of patients with drug-related adverse events (AEs) during the treatment phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI 695501 by evaluation of: * the change from Baseline in DAS28 (ESR) at Week 48 * the proportion of patients meeting American College of Rheumatology 20% (ACR20) response criteria at Week 48 * the proportion of patients who meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition of remission at Week 48 * the proportion of patients with EULAR response (good response, moderate response, or no response) at Week 48.
Study identification
- NCT ID
- NCT02640612
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 430 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 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 22, 2016 (Actual)
- Primary completion
- Nov 1, 2017 (Actual)
- Completion
- Nov 1, 2017 (Actual)
- Last update posted
- Dec 5, 2018
2016 – 2017
United States locations
- U.S. sites
- 31
- U.S. states
- 15
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Mesa | Arizona | 85202 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85032 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85037 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020-4124 | — |
| Advanced Medical Research, LLC | Lakewood | California | 90712 | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | — |
| Orthopedic Research Institute | Boynton Beach | Florida | 33437 | — |
| Science and Research Institute, Inc. | Jupiter | Florida | 33458 | — |
| San Marcus Research Clinic, Inc. | Miami | Florida | 33015 | — |
| L&C Professional Medical Research Institute | Miami | Florida | 33144 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| Lovelace Scientific Resources, Incorporated | Venice | Florida | 34292 | — |
| Goldpoint Clinical Research, LLC | Indianapolis | Indiana | 46260 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | — |
| Arthritis Education and Treatment Center | Grand Rapids | Michigan | 49546 | — |
| Accurate Clinical Research, Inc. | Lincoln | Nebraska | 68516 | — |
| Albuquerque Center For Rheumatology | Albuquerque | New Mexico | 87102 | — |
| STAT Research, Incorporated | Dayton | Ohio | 45417 | — |
| Clinical Research Source, Inc. | Toledo | Ohio | 43606 | — |
| Center for Inflammatory Disease | Nashville | Tennessee | 37205 | — |
| Adriana Pop Moody Clinic PA | Corpus Christi | Texas | 78404 | — |
| Accurate Clinical Management LLC | Houston | Texas | 77004 | — |
| Accurate Clinical Research, Incorporated | Houston | Texas | 77034 | — |
| Rheumatology Clinic Of Houston, P.A. | Houston | Texas | 77065 | — |
| Accurate Clinical Research, Incorporated | Houston | Texas | — | — |
| Arthritis & Osteoporosis Associates LLP | Lubbock | Texas | 79424 | — |
| Heartland Research Associates, LLC | San Antonio | Texas | 78229 | — |
| Danville Orthopedic Clinic, Incorporated | Danville | Virginia | 24541 | — |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | — |
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 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02640612, 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 Dec 5, 2018 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02640612 live on ClinicalTrials.gov.