Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis
NCT ID: NCT01451203
Last Updated: 2024-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
319 participants
INTERVENTIONAL
2011-10-11
2014-10-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PBO + MTX
Participants 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
Placebo
Subcutaneous (SC)
methotrexate (MTX)
oral
CZP + MTX
Participants 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
CZP
SC
methotrexate (MTX)
oral
Interventions
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Placebo
Subcutaneous (SC)
CZP
SC
methotrexate (MTX)
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Subjects who developed RA within one year after onset of RA.
2. Subjects who have never received MTX before (MTX naive)
3. Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）
4. 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 Criteria
* 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
20 Years
64 Years
ALL
No
Sponsors
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UCB Japan Co. Ltd.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Locations
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Chubu Region, , Japan
Chugoku Region, , Japan
Hokkaido Region, , Japan
Kanto Region, , Japan
Kinki Region, , Japan
Kyushu Region, , Japan
Shikoku Region, , Japan
Tohoku Region, , Japan
Countries
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References
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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.
Atsumi 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.
Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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JapicCTI-111636
Identifier Type: OTHER
Identifier Source: secondary_id
CDP870-275-11-001
Identifier Type: -
Identifier Source: org_study_id