Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy
NCT ID: NCT01463059
Last Updated: 2013-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
119 participants
INTERVENTIONAL
2011-10-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo every 2 weeks
Injections administered at week 0, 2, 4, 6, 8 and 10
Placebo
Placebo solution for injection, administered as subcutaneous injections
Olokizumab 60 mg every 2 weeks
Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 60 mg
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
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
Placebo
Placebo solution for injection, administered as subcutaneous injections
Olokizumab 60 mg
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Olokizumab 120 mg every 2 weeks
Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 120 mg
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
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
Placebo
Placebo solution for injection, administered as subcutaneous injections
Olokizumab 120 mg
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
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
Placebo
Placebo solution for injection, administered as subcutaneous injections
Olokizumab 240 mg
Olokizumab 240 mg solution for injection, administered as subcutaneous injections
Interventions
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Placebo
Placebo solution for injection, administered as subcutaneous injections
Olokizumab 60 mg
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Olokizumab 120 mg
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
Olokizumab 240 mg
Olokizumab 240 mg solution for injection, administered as subcutaneous injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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UCB Japan Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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102
Chiba, , Japan
114
Fukuoka, , Japan
115
Fukuoka, , Japan
113
Hiroshima, , Japan
120
Kakogawa, , Japan
118
Kumamoto, , Japan
116
Kurume, , Japan
121
Matsuyama, , Japan
122
Matsuyama, , Japan
107
Nagaoka, , Japan
110
Nagoya, , Japan
103
Narita, , Japan
112
Okayama, , Japan
119
Ōita, , Japan
100
Sapporo, , Japan
117
Sasebo, , Japan
124
Tokorozawa, , Japan
123
Tokyo, , Japan
101
Tomakomai, , Japan
108
Tonami, , Japan
111
Tsu, , Japan
105
Yokohama, , Japan
104
Yotukaido, , Japan
200
Daejeon, , South Korea
201
Junggu, , South Korea
202
Seongdong-gu, , South Korea
203
Seoul, , South Korea
204
Seoul, , South Korea
303
Changhua, , Taiwan
304
Dalin-Town, , Taiwan
305
Hualien City, , Taiwan
300
Kaohsiung City, , Taiwan
301
Taichung, , Taiwan
306
Taichung, , Taiwan
307
Taichung, , Taiwan
302
Taipei, , Taiwan
308
Taipei, , Taiwan
309
Taipei, , Taiwan
310
Taipei, , Taiwan
Countries
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References
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Takeuchi T, Tanaka Y, Yamanaka H, Amano K, Nagamine R, Park W, Shiozawa K, Tsukano M, Wei JC, Shao J, Togo O, Mashimo H. Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial. Mod Rheumatol. 2016;26(1):15-23. doi: 10.3109/14397595.2015.1074648. Epub 2015 Sep 10.
Other Identifiers
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RA0083
Identifier Type: -
Identifier Source: org_study_id
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