Status:

COMPLETED

Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

Lead Sponsor:

UCB Pharma

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)

Detailed Description

This is a Phase IIIB, multi-centre, open-label, follow-up study to study C87076 \[NCT00674362\] designed to continue to assess the safety and efficacy of Certolizumab Pegol. Two different population ...

Eligibility Criteria

Inclusion

  • Patients with established adult rheumatoid arthritis on Disease Modifying Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and:
  • either failed to achieve remission after 6 months of study treatment
  • or flared after the 6 months of study treatment and completed the study (C87076 \[NCT00674362\])

Exclusion

  • All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
  • Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

131 Patients enrolled

Trial Details

Trial ID

NCT00843778

Start Date

January 1 2009

End Date

December 1 2012

Last Update

January 30 2014

Active Locations (25)

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Page 1 of 7 (25 locations)

1

6

Vienna, Austria

2

11

Rennes, France

3

64

Toulouse, France

4

10

Tours, France