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A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

NCT03192969 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-07-12

No results posted yet for this study

Summary

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

Conditions

  • Giant Cell Arteritis

Interventions

DRUG

Abatacept

Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)

OTHER

Placebo

Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes

DRUG

Glucocorticoid Treatment

Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-15
Primary Completion
2020-06-07
Completion
2021-11-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Serbia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03192969 on ClinicalTrials.gov