Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy
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
1 other identifier
interventional
119
3 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Oct 2011
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 27, 2011
CompletedFirst Posted
Study publicly available on registry
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 25, 2013
March 1, 2013
1.3 years
October 27, 2011
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
From Week 0 (Baseline) to Week 12
Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
From Week 0 (Baseline) to Week 12
Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
From Week 0 (Baseline) to Week 12
Study Arms (6)
Placebo every 2 weeks
PLACEBO COMPARATORInjections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 60 mg every 2 weeks
EXPERIMENTALOlokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 60 mg every 4 weeks
EXPERIMENTALOlokizumab 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
EXPERIMENTALOlokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 120 mg every 4 weeks
EXPERIMENTALOlokizumab 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
EXPERIMENTALOlokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
Interventions
Placebo solution for injection, administered as subcutaneous injections
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
Olokizumab 240 mg solution for injection, administered as subcutaneous injections
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
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
Related Publications (1)
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.
PMID: 26358841DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
October 27, 2011
First Posted
November 1, 2011
Study Start
October 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
March 25, 2013
Record last verified: 2013-03