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Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate

NCT00525213 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2009-08-21

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.

Conditions

  • Rheumatoid Arthritis

Interventions

DRUG

Rob 803

two capsules per day during 12 weeks

DRUG

Placebo

two capsules per day during 12 weeks

Sponsors & Collaborators

  • OxyPharma

    lead INDUSTRY

Principal Investigators

  • Lars Klareskog, Professor · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Belgium
  • Bulgaria
  • Georgia
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Serbia
  • Sweden
  • United Kingdom

Study Locations

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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 NCT00525213 on ClinicalTrials.gov