Clinical trial NCT01463059: Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Monoclonal Antibody
Interleukin-6
Olokizumab
CDP6038
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-11-01
Enrollment: 119
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12
timeFrame: From Week 0 (Baseline) to Week 12
Secondary outcomes:
measure: Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
timeFrame: From Week 0 (Baseline) to Week 12
measure: Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
timeFrame: From Week 0 (Baseline) to Week 12
measure: Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
timeFrame: From Week 0 (Baseline) to Week 12
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: 102
city: Fukuoka
country: Japan
facility: 114
city: Fukuoka
country: Japan
facility: 115
city: Hiroshima
country: Japan
facility: 113
city: Kakogawa
country: Japan
facility: 120
city: Kumamoto
country: Japan
facility: 118
city: Kurume
country: Japan
facility: 116
city: Matsuyama
country: Japan
facility: 121
city: Matsuyama
country: Japan
facility: 122
city: Nagaoka
country: Japan
facility: 107
city: Nagoya
country: Japan
facility: 110
city: Narita
country: Japan
facility: 103
city: Oita
country: Japan
facility: 119
city: Okayama
country: Japan
facility: 112
city: Sapporo
country: Japan
facility: 100
city: Sasebo
country: Japan
facility: 117
city: Tokorozawa
country: Japan
facility: 124
city: Tokyo
country: Japan
facility: 123
city: Tomakomai
country: Japan
facility: 101
city: Tonami
country: Japan
facility: 108
city: Tsu
country: Japan
facility: 111
city: Yokohama
country: Japan
facility: 105
city: Yotukaido
country: Japan
facility: 104
city: Daejeon
country: Korea, Republic of
facility: 200
city: Jung-gu
country: Korea, Republic of
facility: 201
city: Seongdong-gu
country: Korea, Republic of
facility: 202
city: Seoul
country: Korea, Republic of
facility: 203
city: Seoul
country: Korea, Republic of
facility: 204
city: Changhua
country: Taiwan
facility: 303
city: Dalin-Town
country: Taiwan
facility: 304
city: Hualien
country: Taiwan
facility: 305
city: Kaohsiung
country: Taiwan
facility: 300
city: Taichung
country: Taiwan
facility: 301
city: Taichung
country: Taiwan
facility: 306
city: Taichung
country: Taiwan
facility: 307
city: Taipei
country: Taiwan
facility: 302
city: Taipei
country: Taiwan
facility: 308
city: Taipei
country: Taiwan
facility: 309
city: Taipei
country: Taiwan
facility: 310
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.