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Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis

NCT02000336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2020-04-10

No results posted yet for this study

Summary

Although cortisone is widely used in the treatment of patients with early rheumatoid arthritis, the best dosage is not known. Therefore we will compare two standard prednisolon starting dosages and placebo in the treatment of patients with early active rheumatoid arthritis on the background of the established therapy with methotrexate. In total 450 patients will be included into the study. Two different treatment arms starting with 10 or 60 mg of prednisolone, and one placebo arm. Duration of intervention is 12 weeks. In parallel, all patients start medication with methotrexate, usual dosage 15 mg/week. Primary efficacy endpoint is progression of radiographic damage after one year compared to baseline. Safety monitoring is performed.

Conditions

  • Progression of Rheumatoid Arthritis

Interventions

DRUG

Prednisolone

To compare two standard p.o. GC starting dosages and the non-use of GCs in the treatment of patients with early active RA on the background of the established 'anchor' therapy with methotrexate (MTX).

DRUG

Placebo

Sponsors & Collaborators

  • Ruhr University of Bochum

    collaborator OTHER

  • Prof. Dr. rer. nat. H.J. Trampisch

    lead OTHER

Principal Investigators

  • Juergen Braun, MD · Rheumazentrum Ruhrgebiet, Herne/Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-03-31
Completion
2019-09-30

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT02000336 on ClinicalTrials.gov