A Study of the Safety and Effectiveness of Liquid 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:November 2005
End Date:February 2012

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A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050

An open ended study in which patients who completed the preceding double-blind study
NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid
Arthritis.


Inclusion Criteria:

Patients must have either failed to achieve an American College of Rheumatology 20 %
(ACR20) response at Weeks 12 and 14 in C87050 [NCT00160602], or must have completed the
entire Week 24 assessment of C87050 [NCT00160602] 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
(RA)

- Any concomitant biological therapy

- Any experimental therapy, within or outside a clinical
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