Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors
2 other identifiers
interventional
319
1 country
8
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 to MTX and have with poor prognostic factors, using inhibition of radiographically confirmed joint damage progression over a one-year period as a primary endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be discontinued, and the subjects will be monitored for one more year (the follow-up period) to investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory purposes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Oct 2011
Typical duration for phase_3 rheumatoid-arthritis
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2011
CompletedStudy Start
First participant enrolled
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
October 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2014
CompletedResults Posted
Study results publicly available
November 20, 2015
CompletedDecember 9, 2024
November 1, 2024
1.9 years
September 25, 2011
October 18, 2015
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).
Baseline and Week 52
Secondary Outcomes (4)
Change From Baseline in mTSS at Week 24
Baseline and Week 24
Clinical Remission Rate: Percentage of Participants Meeting the Disease Activity Score-28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) (DAS28[ESR]) Remission Criteria at Weeks 24 and 52
Week 24 and Week 52
Clinical Remission Rate: Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Simplified Disease Activity Index (SDAI)-Based Remission Criteria at Weeks 24 and 52
Week 24 and Week 52
Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean-based Remission Criteria at Weeks 24 and 52
Week 24 and Week 52
Study Arms (2)
PBO + MTX
PLACEBO COMPARATORParticipants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
CZP + MTX
EXPERIMENTALParticipants who certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- UCB Japan Co. Ltd.collaborator
Study Sites (8)
Unknown Facility
Chubu Region, Japan
Unknown Facility
Chugoku Region, Japan
Unknown Facility
Hokkaido Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Kinki Region, Japan
Unknown Facility
Kyushu Region, Japan
Unknown Facility
Shikoku Region, Japan
Unknown Facility
Tohoku Region, Japan
Related Publications (2)
Atsumi T, Tanaka Y, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Eguchi K, Watanabe A, Origasa H, Yasuda S, Yamanishi Y, Kita Y, Matsubara T, Iwamoto M, Shoji T, Togo O, Okada T, van der Heijde D, Miyasaka N, Koike T. Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation: 2-year results of the C-OPERA study, a phase III randomised trial. Ann Rheum Dis. 2017 Aug;76(8):1348-1356. doi: 10.1136/annrheumdis-2016-210246. Epub 2017 Feb 2.
PMID: 28153828DERIVEDAtsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Yasuda S, Yamanishi Y, Kita Y, Matsubara T, Iwamoto M, Shoji T, Okada T, van der Heijde D, Miyasaka N, Koike T. The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression. Ann Rheum Dis. 2016 Jan;75(1):75-83. doi: 10.1136/annrheumdis-2015-207511. Epub 2015 Jul 2.
PMID: 26139005DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Vice President, Japan/Asia Clinical Development
- Organization
- Astellas Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2011
First Posted
October 13, 2011
Study Start
October 11, 2011
Primary Completion
August 28, 2013
Study Completion
October 20, 2014
Last Updated
December 9, 2024
Results First Posted
November 20, 2015
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.