A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2018 |
| Start Date: | June 2005 |
| End Date: | February 2012 |
A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
An open ended study in which patients who completed the double-blind study CDP870-027
[NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of
Rheumatoid Arthritis (RA).
[NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of
Rheumatoid Arthritis (RA).
Inclusion Criteria:
Patients must have either failed to achieve American College of Rheumatology 20 % Response
Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the
entire Week 52 assessment of C87027 [NCT00152386] trial.
Exclusion Criteria:
- A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or
Ankylosing Spondylitis)
- A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia)
that in the Investigator's opinion is symptomatic enough to interfere with evaluation
of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
- Any concomitant biological therapy
- Any experimental therapy, within or outside a clinical trial
We found this trial at
19
sites
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