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Abatacept Treatment in Polymyositis and Dermatomyositis

NCT01315938 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-11-06

No results posted yet for this study

Summary

The aim of this study is to investigate the efficacy and safety of abatacept in patients with Dermatomyositis (DM) and polymyositis (PM) refractory to conventional treatment using a randomised trial design with delayed start in one arm. Abatacept will be administered intravenously to participants at a dose based on body weight at the screening visit followed by six follow-up treatments (Active treatment arm). Abatacept will also be administered intravenously to participants at a dose based on body weight starting at 3 months followed by six follow-up treatments (Delayed-onset treatment arm). The International Myositis Assessment and Clinical Studies Group (IMACS) preliminary definition of improvement (DOI) will be used for assessment.

Conditions

  • Polymyositis
  • Dermatomyositis

Interventions

DRUG

Abatacept Active Treatment

Participants will be treated with abatacept by intravenous infusions a total of seven times at week(s) 0, 2, 4, 8, 12, 16 and 20 weeks.

DRUG

Abatacept Delayed-Onset Treatment

Participants will be treated with abatacept for 6 months and received a total of seven intravenous infusions at weeks 12, 14, 16, 20, 24, 28 and 32.

Sponsors & Collaborators

  • Institute of Rheumatology, Prague

    collaborator OTHER

  • King's College Hospital NHS Trust

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Ingrid E Lundberg, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-11-28
Completion
2013-11-28

Countries

  • Czechia
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT01315938 on ClinicalTrials.gov