Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial
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:||December 2015|
|Estimated Primary Completion Date:||December 2014 (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.
While generalized osteoporosis causes tremendous disability in patients with RA and occurs relatively frequently in such patients, there has been little research on treatments for osteoporosis in patients with RA. Not only are there important questions about the effects of teriparatide on BMD in patients with RA, but little is known about how it might affect localized bone erosions or RA disease activity.
Recent data in a mouse model of RA suggest that intermittent PTH in the setting of potent immunosuppressives may indeed heal bone erosions. This study showed an additive effect of PTH in addition to a biologic on erosion healing. To the best of our knowledge, this has yet to be demonstrated in humans. That is the primary aim of the proposed study.
II. Objectives and Hypotheses:
To assess the effects of teriparatide among a group of patients with RA and erosions, all using biologics, with respect to:
- Joint erosion volume by 3D CT scan;
- Lumbar BMD by DXA;
- Hip BMD by DXA; and
- RA disease activity measured by the Disease Activity Score (DAS) and acute phase reactants.
The hypotheses to be tested include:
- Joint erosion scores, measured by 3D CT scan, will be significantly improved at study completion in patients taking teriparatide.
- Teriparatide will significantly increase BMD at all sites as measured by DXA.
- RA disease activity measures will be stable during the study year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400516
|Contact: Daniel H Solomon, MD, MPHemail@example.com|
|Contact: Emily Lo, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Daniel H Solomon, MD, MPH 617-732-5356|
|Contact: Emily Lo, MPH 617-732-8169|
|Principal Investigator: Daniel H. Solomon, MD,MPH|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Marcy B. Bolster, M.D. 617-726-7938|
|Contact: Emily Lo 617-732-8169|
|Sub-Investigator: Marcy B. Bolster, M.D.|
|University of Massachusetts Medical School||Recruiting|
|Worcester, Massachusetts, United States, 01605|
|Contact: Ellen M. Gravallese, MD 508-856-8730|
|Contact: Jonathan Kay, MD 508-334-6273|
|Sub-Investigator: Ellen M. Gravallese, MD|
|Sub-Investigator: Jonathan Kay, MD|
|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|