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Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis

NCT01023256 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2014-10-24

Study results available
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Summary

GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.

Conditions

Interventions

DRUG

MOR103

MOR103 0.3 mg/kg or placebo iv x 4 doses

DRUG

MOR103

MOR103 1.0 mg/kg or placebo iv x 4 doses

DRUG

MOR103

MOR103 1.5 mg/kg or placebo iv x 4 doses

Sponsors & Collaborators

  • MorphoSys AG

    lead INDUSTRY

Principal Investigators

  • Roman P Korolkiewicz, MD, PhD · MorphoSys AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Bulgaria
  • Germany
  • Netherlands
  • Poland
  • Ukraine

More Related Trials

Entities

Diseases

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 NCT01023256 on ClinicalTrials.gov