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

March 19, 2013 updated by: UCB Japan Co. Ltd.

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

The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.

Study Overview

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo every 2 weeks
Injections administered at week 0, 2, 4, 6, 8 and 10
Placebo solution for injection, administered as subcutaneous injections
EXPERIMENTAL: Olokizumab 60 mg every 2 weeks
Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Other Names:
  • CDP6038
EXPERIMENTAL: 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 solution for injection, administered as subcutaneous injections
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
Other Names:
  • CDP6038
EXPERIMENTAL: Olokizumab 120 mg every 2 weeks
Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
Other Names:
  • CDP6038
EXPERIMENTAL: 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 solution for injection, administered as subcutaneous injections
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
Other Names:
  • CDP6038
EXPERIMENTAL: 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 solution for injection, administered as subcutaneous injections
Olokizumab 240 mg solution for injection, administered as subcutaneous injections
Other Names:
  • CDP6038

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From Week 0 (Baseline) to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
Time Frame: 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.
From Week 0 (Baseline) to Week 12
Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
Time Frame: 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.
From Week 0 (Baseline) to Week 12
Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
Time Frame: 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.
From Week 0 (Baseline) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (ESTIMATE)

November 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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