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Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial

NCT01400516 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-04-11

Study results available
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Summary

Summary:

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.

Hypothesis:

The investigators hypothesize that the combination of teriparatide with biologic will be much more effective at retarding erosion progression then a biologic alone.

Conditions

Interventions

DRUG

Teriparatide

20 μg, subcutaneous injection, 1 injection per day

DRUG

calcium citrate

1000 mg of calcium citrate

DRUG

Vitamin D

800 IU of Vitamin D

DRUG

TNF antagonist

TNF antagonist as prescribed in clinical practice (such as etanercept or adalimumab)

Sponsors & Collaborators

Principal Investigators

  • Daniel H Solomon, MD, MPH · Brigham and Women's Hospital

  • Ellen M. Gravallese, MD · University of Massachusetts, Worcester

  • Jonathan Kay, MD · University of Massachusetts, Worcester

  • Marcy B. Bolster, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-07-30
Completion
2016-07-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400516 on ClinicalTrials.gov