Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial (TERA)
The investigators propose a randomized controlled open label study of teriparatide in men or women with rheumatoid arthritis and joint erosions. Specifically, the investigators will examine whether teriparatide in combination with a biologic can retard the development of joint erosions. The study will be conducted at Brigham and Women's Hospital Arthritis Center, several Brigham and Women's Hospital Arthritis Center satellite practices, the University of Massachusetts Medical Center, and Massachusetts General Hospital.
The investigators hypothesize that the combination of teriparatide with biologic will be much more effective at retarding erosion progression then a biologic alone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial|
- Joint Erosion by 3D CT scan [ Time Frame: 12 months ] [ Designated as safety issue: No ]Joint erosion scores, measured by 3D CT scan, will be significantly improved at study completion in patients taking teriparatide
- Lumbar by DXA [ Time Frame: 12 months ] [ Designated as safety issue: No ]Teriparatide will significantly increase BMD at all sites as measured by DXA.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
The subjects who are in treatment arm will receive teriparatide with a biologic. A second year of teriparatide will be offered to all interested subjects.
20 mcg, subcutaneous injection, 1 injection per day
Other Name: Forteo
No Intervention: Control Arm
The subjects randomized to the control arm will undergo the same testing as those in the treatment arm and will be offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400516
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01605|
|Principal Investigator:||Daniel H Solomon, MD, MPH||Brigham and Women's Hospital|
|Principal Investigator:||Ellen M. Gravallese, MD||University of Massachusetts, Worcester|
|Principal Investigator:||Jonathan Kay, MD||University of Massachusetts, Worcester|
|Principal Investigator:||Marcy B. Bolster, M.D.||Massachusetts General Hospital|