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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Olokizumab 60 mg
Olokizumab 120 mg
Olokizumab 240 mg
Sponsored by
UCB Japan Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Monoclonal Antibody, Interleukin-6, Olokizumab, CDP6038

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 102
  • 114
  • 115
  • 113
  • 120
  • 118
  • 116
  • 121
  • 122
  • 107
  • 110
  • 103
  • 119
  • 112
  • 100
  • 117
  • 124
  • 123
  • 101
  • 108
  • 111
  • 105
  • 104
  • 200
  • 201
  • 202
  • 203
  • 204
  • 303
  • 304
  • 305
  • 300
  • 301
  • 306
  • 307
  • 302
  • 308
  • 309
  • 310

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo every 2 weeks

Olokizumab 60 mg every 2 weeks

Olokizumab 60 mg every 4 weeks

Olokizumab 120 mg every 2 weeks

Olokizumab 120 mg every 4 weeks

Olokizumab 240 mg very 4 weeks

Arm Description

Injections administered at week 0, 2, 4, 6, 8 and 10

Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10

Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10

Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10

Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10

Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at 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
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
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.

Full Information

First Posted
October 27, 2011
Last Updated
March 19, 2013
Sponsor
UCB Japan Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01463059
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Japan Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Monoclonal Antibody, Interleukin-6, Olokizumab, CDP6038

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo every 2 weeks
Arm Type
Placebo Comparator
Arm Description
Injections administered at week 0, 2, 4, 6, 8 and 10
Arm Title
Olokizumab 60 mg every 2 weeks
Arm Type
Experimental
Arm Description
Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
Arm Title
Olokizumab 60 mg every 4 weeks
Arm Type
Experimental
Arm Description
Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
Arm Title
Olokizumab 120 mg every 2 weeks
Arm Type
Experimental
Arm Description
Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
Arm Title
Olokizumab 120 mg every 4 weeks
Arm Type
Experimental
Arm Description
Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
Arm Title
Olokizumab 240 mg very 4 weeks
Arm Type
Experimental
Arm Description
Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for injection, administered as subcutaneous injections
Intervention Type
Biological
Intervention Name(s)
Olokizumab 60 mg
Other Intervention Name(s)
CDP6038
Intervention Description
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Intervention Type
Biological
Intervention Name(s)
Olokizumab 120 mg
Other Intervention Name(s)
CDP6038
Intervention Description
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
Intervention Type
Biological
Intervention Name(s)
Olokizumab 240 mg
Other Intervention Name(s)
CDP6038
Intervention Description
Olokizumab 240 mg solution for injection, administered as subcutaneous injections
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
Description
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.
Time Frame
From Week 0 (Baseline) to Week 12
Title
Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
Description
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.
Time Frame
From Week 0 (Baseline) to Week 12
Title
Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
Description
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.
Time Frame
From Week 0 (Baseline) to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
102
City
Chiba
Country
Japan
Facility Name
114
City
Fukuoka
Country
Japan
Facility Name
115
City
Fukuoka
Country
Japan
Facility Name
113
City
Hiroshima
Country
Japan
Facility Name
120
City
Kakogawa
Country
Japan
Facility Name
118
City
Kumamoto
Country
Japan
Facility Name
116
City
Kurume
Country
Japan
Facility Name
121
City
Matsuyama
Country
Japan
Facility Name
122
City
Matsuyama
Country
Japan
Facility Name
107
City
Nagaoka
Country
Japan
Facility Name
110
City
Nagoya
Country
Japan
Facility Name
103
City
Narita
Country
Japan
Facility Name
119
City
Oita
Country
Japan
Facility Name
112
City
Okayama
Country
Japan
Facility Name
100
City
Sapporo
Country
Japan
Facility Name
117
City
Sasebo
Country
Japan
Facility Name
124
City
Tokorozawa
Country
Japan
Facility Name
123
City
Tokyo
Country
Japan
Facility Name
101
City
Tomakomai
Country
Japan
Facility Name
108
City
Tonami
Country
Japan
Facility Name
111
City
Tsu
Country
Japan
Facility Name
105
City
Yokohama
Country
Japan
Facility Name
104
City
Yotukaido
Country
Japan
Facility Name
200
City
Daejeon
Country
Korea, Republic of
Facility Name
201
City
Jung-gu
Country
Korea, Republic of
Facility Name
202
City
Seongdong-gu
Country
Korea, Republic of
Facility Name
203
City
Seoul
Country
Korea, Republic of
Facility Name
204
City
Seoul
Country
Korea, Republic of
Facility Name
303
City
Changhua
Country
Taiwan
Facility Name
304
City
Dalin-Town
Country
Taiwan
Facility Name
305
City
Hualien
Country
Taiwan
Facility Name
300
City
Kaohsiung
Country
Taiwan
Facility Name
301
City
Taichung
Country
Taiwan
Facility Name
306
City
Taichung
Country
Taiwan
Facility Name
307
City
Taichung
Country
Taiwan
Facility Name
302
City
Taipei
Country
Taiwan
Facility Name
308
City
Taipei
Country
Taiwan
Facility Name
309
City
Taipei
Country
Taiwan
Facility Name
310
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26358841
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. Erratum In: Mod Rheumatol. 2018 Sep;28(5):911-912.
Results Reference
derived

Learn more about this trial

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

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