Status:
COMPLETED
Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)
Lead Sponsor:
UCB Pharma
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
Detailed Description
Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced...
Eligibility Criteria
Inclusion
- Patients must be able to understand the written Informed Consent Form (ICF)
- Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
- Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
- Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
- Patients must be willing to comply with protocol
Exclusion
- Patients must not have a diagnosis of any other inflammatory Arthritis
- Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
- Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
- Patients who do not meet the Medical History Exclusion criteria, as defined per protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00753454
Start Date
September 1 2008
End Date
May 1 2011
Last Update
August 1 2018
Active Locations (40)
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1
Huntsville, Alabama, United States
2
Paradise Valley, Arizona, United States
3
Tucson, Arizona, United States
4
Little Rock, Arkansas, United States