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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Japan
      • 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
  • Korea, Republic of
      • 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
  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo every 2 weeks
Injections administered at week 0, 2, 4, 6, 8 and 10
Biological: Placebo
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
Biological: Olokizumab 60 mg
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
Biological: Placebo
Placebo solution for injection, administered as subcutaneous injections
Biological: Olokizumab 60 mg
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
Biological: Olokizumab 120 mg
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
Biological: Placebo
Placebo solution for injection, administered as subcutaneous injections
Biological: Olokizumab 120 mg
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
Biological: Placebo
Placebo solution for injection, administered as subcutaneous injections
Biological: Olokizumab 240 mg
Olokizumab 240 mg solution for injection, administered as subcutaneous injections
Other Names:
  • CDP6038

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Japan Co. Ltd.

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RA0083

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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