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Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia

NCT02778906 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2020-03-10

No results posted yet for this study

Summary

This is a randomised double-blinded placebo-controlled multi centre study in 98 patients with ACPA positive arthralgia. The study is composed of 2 arms with a 1:1 randomisation at baseline: Treatment phase will be 6 months. Group 1: Abatacept s.c. 125 mg weekly for 6 months vs. Group 2: Placebo s.c. for 6 months. After 6 months both groups will run into the follow up period for another 12 months up to month 18. Patients developing arthritis will be treated according to local guidelines.

Conditions

Interventions

DRUG

Abatacept

Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis

DRUG

Placebo

Administration of the comparator s.c. weekly in comparable to verum

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Georg Schett, Prof. Dr. univ. · University Clinic Erlangen, Department of Internal Medicine 3, Rheumatology & Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Germany

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 NCT02778906 on ClinicalTrials.gov