BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT02137226. 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
Efficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®. Secondary Objectives: The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.
Study identification
- NCT ID
- NCT02137226
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 645 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 26, 2015 (Actual)
- Primary completion
- Mar 3, 2016 (Actual)
- Completion
- Oct 18, 2016 (Actual)
- Last update posted
- Jan 19, 2018
2015 – 2016
United States locations
- U.S. sites
- 63
- U.S. states
- 26
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| Rheumatology Associates | Birmingham | Alabama | 35205 | — |
| Achieve Clinical Research, LLC | Birmingham | Alabama | 35216 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Glendale | Arizona | 85304 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Mesa | Arizona | 85202 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85032-9384 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85037 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020-4124 | — |
| Advanced Medical Research, LLC | La Palma | California | 90623 | — |
| ProHealth Partners | Long Beach | California | 90808 | — |
| The Permanente Medical Group | Santa Clara | California | 95051 | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | — |
| Medvin Clinical Research | Whittier | California | 90606 | — |
| Alpine Clinical Research Center | Boulder | Colorado | 80304 | — |
| Orthopedic Research Institute | Boynton Beach | Florida | 33437 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Universal Clinical Research | Coral Gables | Florida | 33134 | — |
| 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 | — |
| Family Clinical Trials, Incorporated | Pembroke Pines | Florida | 33026 | — |
| Physician Research Collaboration | South Miami | Florida | 33143 | — |
| West Broward Rheumatology Associates, Incorporated | Tamarac | Florida | 33321 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| McIlwain Medical Group, PA | Tampa | Florida | 33613 | — |
| Lovelace Scientific Resources, Incorporated | Venice | Florida | 34292 | — |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | — |
| Goldpoint Clinical Research, LLC | Indianapolis | Indiana | 46260 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| The Arthritis & Diabetes Clinic, Incorporated | Monroe | Louisiana | 71203 | — |
| Klein and Associates, M.D., P.A. | Cumberland | Maryland | 21502 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Arthritis Education and Treatment Center | Grand Rapids | Michigan | 49503 | — |
| North MS Medical Clinics, Incorporated | Tupelo | Mississippi | 38801 | — |
| Glacier View Research Institute | Kalispell | Montana | 59901 | — |
| Accurate Clinical Research, Inc. | Lincoln | Nebraska | 68516 | — |
| NJP Clinical Research | Clifton | New Jersey | 07012 | — |
| Albuquerque Center For Rheumatology | Albuquerque | New Mexico | 87102 | — |
| Anna Imperato, MD PLLC | Manhasset | New York | 11030 | — |
| Box Arthritis & Rheumatology of the Carolinas | Charlotte | North Carolina | 28210 | — |
| Medication Management, LLC | Greensboro | North Carolina | 27408 | — |
| PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| STAT Research, Incorporated | Dayton | Ohio | 45417 | — |
| Clinical Research Source, Inc. | Perrysburg | Ohio | 43551 | — |
| Altoona Center for Clinical Research, P.C. | Duncansville | Pennsylvania | 16635 | — |
| Mountain View Clinical Research | Greer | South Carolina | 29651 | — |
| Center for Inflammatory Disease | Nashville | Tennessee | 37203-2032 | — |
| Austin Regional Clinic | Austin | Texas | 78731 | — |
| Adriana Pop Moody Clinic PA | Corpus Christi | Texas | 78404 | — |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | — |
| Accurate Clinical Management LLC | Houston | Texas | 77004 | — |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77008 | — |
| Accurate Clinical Research, Incorporated | Houston | Texas | 77034 | — |
| Rheumatology Clinic Of Houston, P.A. | Houston | Texas | 77070 | — |
| Accurate Clinical Research, Incorporated | Houston | Texas | 77084 | — |
| Houston Rheumatology Consultants, PLLC | Houston | Texas | 77089 | — |
| Arthritis & Osteoporosis Associates LLP | Lubbock | Texas | 79424 | — |
| Accurate Clinical Research, Incorporated | Nassau Bay | Texas | 77058 | — |
| 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 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02137226, 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 Jan 19, 2018 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02137226 live on ClinicalTrials.gov.