Trial record 1 of 2 for:
NCT01463059
Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01463059 |
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Recruitment Status :
Completed
First Posted : November 1, 2011
Last Update Posted : March 25, 2013
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Sponsor:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
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Brief Summary:
The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Biological: Placebo Biological: Olokizumab 60 mg Biological: Olokizumab 120 mg Biological: Olokizumab 240 mg | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 119 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | February 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo every 2 weeks
Injections administered at week 0, 2, 4, 6, 8 and 10
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Biological: Placebo
Placebo solution for injection, administered as subcutaneous injections |
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Experimental: Olokizumab 60 mg every 2 weeks
Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
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Biological: Olokizumab 60 mg
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Other Name: CDP6038 |
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Experimental: Olokizumab 60 mg every 4 weeks
Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
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Biological: Placebo
Placebo solution for injection, administered as subcutaneous injections Biological: Olokizumab 60 mg Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Other Name: CDP6038 |
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Experimental: Olokizumab 120 mg every 2 weeks
Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
|
Biological: Olokizumab 120 mg
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
Other Name: CDP6038 |
|
Experimental: Olokizumab 120 mg every 4 weeks
Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
|
Biological: Placebo
Placebo solution for injection, administered as subcutaneous injections Biological: Olokizumab 120 mg Olokizumab 120 mg solution for injection, administered as subcutaneous injections
Other Name: CDP6038 |
|
Experimental: Olokizumab 240 mg very 4 weeks
Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
|
Biological: Placebo
Placebo solution for injection, administered as subcutaneous injections Biological: Olokizumab 240 mg Olokizumab 240 mg solution for injection, administered as subcutaneous injections
Other Name: CDP6038 |
Primary Outcome Measures :
- Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12 [ Time Frame: From Week 0 (Baseline) to Week 12 ]
Secondary Outcome Measures :
- Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12 [ Time Frame: From Week 0 (Baseline) to Week 12 ]Number of subjects who achieve ACR 20 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.
- Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12 [ Time Frame: From Week 0 (Baseline) to Week 12 ]Number of subjects who achieve ACR 50 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.
- Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12 [ Time Frame: From Week 0 (Baseline) to Week 12 ]Number of subjects who achieve ACR 70 will be calculated at week 12. The calculations is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
- Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR >28mm/hour
- Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
- Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
- Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception
Exclusion Criteria:
- Have a diagnosis of any other inflammatory arthritis
- Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
- Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
- Subjects with known concurrent acute or chronic viral hepatitis B or C infection
- Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
- Subjects with known history of or current clinically active infection
- Subjects at high risk of infection
- Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
- Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
- Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463059
Locations
Show 39 study locations
Sponsors and Collaborators
UCB Japan Co. Ltd.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Japan Co. Ltd. |
| ClinicalTrials.gov Identifier: | NCT01463059 |
| Other Study ID Numbers: |
RA0083 |
| First Posted: | November 1, 2011 Key Record Dates |
| Last Update Posted: | March 25, 2013 |
| Last Verified: | March 2013 |
Keywords provided by UCB Pharma ( UCB Japan Co. Ltd. ):
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Rheumatoid Arthritis Monoclonal Antibody Interleukin-6 Olokizumab CDP6038 |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |