Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT01682512. 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, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely 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.
The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.
Study identification
- NCT ID
- NCT01682512
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 294 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
- Sep 5, 2012 (Actual)
- Primary completion
- Nov 17, 2015 (Actual)
- Completion
- Oct 12, 2016 (Actual)
- Last update posted
- Jan 30, 2018
2012 – 2016
United States locations
- U.S. sites
- 54
- U.S. states
- 25
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rheumatology Associates | Birmingham | Alabama | 35205 | — |
| Achieve Clinical Research, LLC | Birmingham | Alabama | 35216 | — |
| Arizona Arthritis & Rheumatology Associates, P.C. | Glendale | Arizona | 85304 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Mesa | Arizona | 85032 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Mesa | Arizona | 85202 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85307 | — |
| Little Rock Diagnostic Clinic | Little Rock | Arkansas | 72205 | — |
| Medvin Clinical Research | Covina | California | 91723 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | — |
| Advanced Medical Research, LLC | Lakewood | California | 90712 | — |
| Premiere Clinical Research, LLC | Lakewood | California | 90712 | — |
| ProHealth Partners | Long Beach | California | 90808 | — |
| San Diego Arthritis Medical Clinic | San Diego | California | 92108 | — |
| Arthritis Center Medical Group | Santa Maria | California | 93454 | — |
| Westlake Medical Research | Thousand Oaks | California | 91360 | — |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | — |
| Nascimento, Joao (Private Practice) | Bridgeport | Connecticut | 06606 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| New Horizon Research Center | Miami | Florida | 33175 | — |
| Arthritis Associates, Inc. | Orlando | Florida | 32804 | — |
| Family Clinical Trials, Incorporated | Pembroke Pines | Florida | 33026 | — |
| Arthritis & Rheumatology Associates of Palm Beach | Tampa | Florida | 33609 | — |
| Lovelace Scientific Resources, Incorporated | Venice | Florida | 34292 | — |
| Coeur d'Alene Arthritis Clinical Trials | Coeur d'Alene | Idaho | 83814 | — |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | — |
| Apex Medical Research | Chicago | Illinois | 60616 | — |
| International Clinical Research | Overland Park | Kansas | 66210 | — |
| Columbia Medical Practice, PC | Columbia | Maryland | 21045 | — |
| Klein and Associates, M.D., P.A. | Cumberland | Maryland | 21502 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | — |
| West Michigan Rheumatology, PLLC | Grand Rapids | Michigan | 49546 | — |
| Arthritis Consultants, Inc | St Louis | Missouri | 63141 | — |
| Westroads Clinical Research | Omaha | Nebraska | 68114 | — |
| Summit Medical Group | Clifton | New Jersey | 07012 | — |
| Atlantic Coast Research | Toms River | New Jersey | 08755 | — |
| Albuquerque Center For Rheumatology | Albuquerque | New Mexico | 87102 | — |
| Arthritis and Osteoporosis Medical Associates, PLLC | Brooklyn | New York | 11201 | — |
| Box Arthritis & Rheumatology of the Carolinas | Charlotte | North Carolina | 28210 | — |
| Medication Management, LLC | Greensboro | North Carolina | 27408 | — |
| STAT Research, Incorporated | Dayton | Ohio | 45417 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Altoona Center for Clinical Research, P.C. | Duncansville | Pennsylvania | 16635 | — |
| Office of Dr. Ramesh C. Gupta | Memphis | Tennessee | 38119 | — |
| Center for Inflammatory Disease | Nashville | Tennessee | 37203 | — |
| ClinRX Research LLC | Carrollton | Texas | 75007 | — |
| Adriana Pop Moody Clinic PA | Corpus Christi | Texas | 78404 | — |
| Heartland Research Associates, LLC | Houston | Texas | 77034 | — |
| ClinRx Research LLC | McKinney | Texas | 75069 | — |
| Heartland Research Associates, LLC | Webster | Texas | 77598 | — |
| The Seattle Arthritis Clinic, PS | Seattle | Washington | 98133 | — |
| Tacoma Center for Arthritis Research, PS | Tacoma | Washington | 98405-2395 | — |
| Rheumatology and Pulmonary Clinic | Beckley | West Virginia | 25801 | — |
| Mountain State Clinical Research | Clarksburg | West Virginia | 26301 | — |
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 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01682512, 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 30, 2018 · Synced Oct 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01682512 live on ClinicalTrials.gov.