Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00796705 |
Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative tumor necrosis factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Adalimumab Drug: Adalimumab placebo Drug: Etanercept |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Switching Anti-TNF-Alpha Agents in Patients With RA With An Inadequate Response to TNF-Alpha Inhibition |
Estimated Enrollment: | 144 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Participants will receive an injection of adalimumab or adalimumab placebo each week for 12 weeks
|
Drug: Adalimumab
40 mg recombinant human IgG1 monoclonal antibody administered subcutaneously
Drug: Adalimumab placebo
1.0 ml .9% saline placebo administered subcutaneously
|
2: Experimental
Participants will receive an injection of etanercept each week for 12 weeks
|
Drug: Etanercept
50 mg dimeric fusion protein administered subcutaneously
|
Over the past 10 years, advancements in biotechnology have revolutionized RA therapeutics with biologically-derived immunodulating compounds. TNF-alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the effectiveness of switching to an alternative tumor necrosis factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA who have had inadequate clinical response to the study drugs etanercept and adalimumab.
This study will last approximately 16 weeks. Participants will be randomized into two arms and receive injections once per week for 12 weeks. Participants in Arm A will receive alternating subcutaneous adalimumab and adalimumab placebo injections. Participants in Arm B will receive subcutaneous etanercept injections.
This study consists of thirteen study visits after randomization. Study visits will occur on a weekly basis for 12 weeks prior to a follow-up visit at Week 16. A vital signs measurement and adverse event assessment will occur at each visit. A physical exam, assessment of tender and swollen joints, medication assessment, and blood collection will occur at Weeks 4, 8, 12, and 16.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama | Not yet recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Randall Parks, RN, MBA 202-934-7727 Randall.parks@ccc.uab.edu | |
Principal Investigator: Jeffrey Curtis, MD, MPH | |
United States, California | |
Stanford University | Not yet recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Mark Genovese 650-498-4528 jhillygu@stanford.edu | |
United States, Colorado | |
University of Colorado | Not yet recruiting |
Aurora, Colorado, United States, 34239 | |
Contact: Jan Wagner, RN 303-724-7516 Janice.Wagner@UCHSC.edu | |
United States, Florida | |
Sarasota Arhtritis Research Center | Not yet recruiting |
Sarasota, Florida, United States, 34239 | |
Contact: Deb Bevelacqua 941-366-1244 arthritisresearch@comcast.net | |
Principal Investigator: Jeffrey Kaine, MD | |
Tampa Medical Group | Not yet recruiting |
Tampa, Florida, United States, 33614 | |
Contact: Cindy Crawford 813-875-9742 research@tampamedicalgroup.com | |
Principal Investigator: Michael Burnette, MD | |
United States, Michigan | |
Justus Fiechtner, MD, PC | Not yet recruiting |
Lansing, Michigan, United States, 48910 | |
Contact: Miguel Salazar, BS 417-272-9727 researchinfo21@hotmail.com | |
Principal Investigator: Justus Fiechtner, MD | |
United States, New York | |
Feinstein Institute for Medical Research NS-LIJ | Not yet recruiting |
Manhassett, New York, United States, 14642 | |
Contact: Andrew Shaw 516-562-2591 anshaw@nshs.edu | |
Principal Investigator: Meggan Mackay, MD | |
University of Rochester | Not yet recruiting |
Rochester, New York, United States, 14642 | |
Contact: Debbie Campbell, RN 585-275-1635 Debbie_Campbell@urmc.rochester.edu | |
Principal Investigator: Jennifer Anolik, MD | |
United States, North Carolina | |
Carolina Bone and Joint | Not yet recruiting |
Charlotte, North Carolina, United States, 28210 | |
Contact: Sophia Rosemond, MS, CCRC 704-541-3055 ext 112 srosemond@bonesrus.org | |
Duke University Medical Center | Not yet recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Edna Scarlett 919-684-6150 scarl001@mc.duke.edu | |
Principal Investigator: E. William St. Clair, MD | |
United States, Pennsylvania | |
Altoona Center for Clinical Research | Not yet recruiting |
Duncansville, Pennsylvania, United States, 16635 | |
Contact: Ellen Rosen 814-693-0300 ext 224 ellenrosen1125@yahoo.com | |
Contact: Ashli Weyandt 814-693-0300 ext 154 AshliWeyandt1125@yahoo.com | |
Principal Investigator: Alan Kivitz, MD | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15260 | |
Contact: Larry Moreland, MD 412-648-0148 morelandl@dom.pitt.edu | |
United States, Utah | |
University of Utah | Not yet recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Tracy Frech, MD 801-585-6468 Tracy.Frech@hsc.utah.edu |
Study Chair: | Larry Moreland, MD | University of Pittsburgh |
Study Chair: | Mark Genovese, MD | Stanford University |
Responsible Party: | DAIT/NIAID ( Associate Director. Clinical Research Program ) |
Study ID Numbers: | DAIT ARA05 |
Study First Received: | November 20, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00796705 |
Health Authority: | United States: Federal Government |
Antibodies, Monoclonal Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases TNFR-Fc fusion protein Adalimumab Immunoglobulins |
Anti-Inflammatory Agents Immunologic Factors Immune System Diseases Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |