Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

Phase 2

Completed

Interventions: Biological: Placebo
Biological: Olokizumab 60 mg
Biological: Olokizumab 120 mg
Biological: Olokizumab 240 mg

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo every 2 weeks	Placebo	Injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 60 mg every 2 weeks	Olokizumab 60 mg	Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 60 mg every 4 weeks	Placebo	Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
Olokizumab 60 mg every 4 weeks	Olokizumab 60 mg	Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
Olokizumab 120 mg every 2 weeks	Olokizumab 120 mg	Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 120 mg every 4 weeks	Placebo	Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
Olokizumab 120 mg every 4 weeks	Olokizumab 120 mg	Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
Olokizumab 240 mg very 4 weeks	Placebo	Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
Olokizumab 240 mg very 4 weeks	Olokizumab 240 mg	Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12	From Week 0 (Baseline) to Week 12

Secondary Outcome Measures

Name	Time	Method
Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12	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	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	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.

Locations (39): 203
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Seoul, Korea, Republic of
204
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Seoul, Korea, Republic of
114
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Fukuoka, Japan
302
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Taipei, Taiwan
309
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Taipei, Taiwan
118
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Kumamoto, Japan
116
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Kurume, Japan
121
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Matsuyama, Japan
115
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Fukuoka, Japan
102
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Chiba, Japan
120
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Kakogawa, Japan
110
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Nagoya, Japan
122
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Matsuyama, Japan
103
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Narita, Japan
100
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Sapporo, Japan
119
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Oita, Japan
112
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Okayama, Japan
101
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Tomakomai, Japan
201
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Jung-gu, Korea, Republic of
202
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Seongdong-gu, Korea, Republic of
200
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Daejeon, Korea, Republic of
306
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Taichung, Taiwan
308
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Taipei, Taiwan
310
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Taipei, Taiwan
108
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Tonami, Japan
113
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Hiroshima, Japan
303
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Changhua, Taiwan
117
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Sasebo, Japan
105
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Yokohama, Japan
305
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Hualien, Taiwan
301
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Taichung, Taiwan
304
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Dalin-Town, Taiwan
307
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Taichung, Taiwan
111
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Tsu, Japan
104
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Yotukaido, Japan
300
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Kaohsiung, Taiwan
107
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Nagaoka, Japan
123
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Tokyo, Japan
124
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Tokorozawa, Japan