Status:
COMPLETED
Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
UCB Japan Co. Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-64 years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis (RA) who are naive t...
Detailed Description
This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.
Eligibility Criteria
Inclusion
- Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria:
- Subjects who developed RA within one year after onset of RA.
- Subjects who have never received MTX before (MTX naive)
- Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）
- Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor prognostic factors. The anti-CCP antibody positive is essential for every patient.
Exclusion
- Patients who have a diagnosis of any other type of inflammatory arthritis.
- Patients who have a secondary, non-inflammatory type of arthritis.
- Patients who have used with MTX, reflunomide, or any other biologics prior to the start of study drug administration.
- Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
- Patients who currently have, or who have a history of, tuberculosis.
- Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
- Patients who currently have, or have a history of, malignant tumor
- Female patients who are breastfeeding or pregnant, who are of childbearing potential
Key Trial Info
Start Date :
October 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2014
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT01451203
Start Date
October 11 2011
End Date
October 20 2014
Last Update
December 9 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan