Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

July 16, 2024 updated by: UCB Pharma

Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.

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.

Detailed Description

CDP6038 is a protein (antibody) that blocks interleukin-6 (IL-6), a substance involved in the inflammation associated with rheumatoid arthritis. This is a multicenter, 12-week, randomized, double-blind, placebo- and active- controlled study comparing several doses and dosage regimens (every 2 weeks and every 4 weeks) of CDP6038 to placebo and tocilizumab in patients with active rheumatoid arthritis who have had an unsuccessful response to methotrexate and previous anti-TNF therapy. The study will test if CDP6038 is more efficacious than placebo in reducing the signs and symptoms of rheumatoid arthritis at 12 weeks while maintaining an adequate safety profile. In order to maintain the study blinding all subjects will be given a subcutaneous (sc) injection (under the skin) every 2 weeks, as well as an intravenous (iv) infusion every 4 weeks. In addition subjects must remain on stable weekly doses of methotrexate. Assessments during the study include evaluations of joint pain and swelling, laboratory blood and urine tests, physical examinations, vital signs, electrocardiograms, and questionnaires. Subjects who complete the 12-week study will be eligible to enroll in a long-term extension study receiving CDP6038.

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.
221

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

  • Belgium
      • Brussels, Belgium
        • 401
      • Liege, Belgium
        • 400
  • United Kingdom
      • Essex, United Kingdom
        • 206
      • London, United Kingdom
        • 205
      • Newcastle Upon Tyne, United Kingdom
        • 204
      • Southampton, United Kingdom
        • 208
    • Devon
      • Torquay, Devon, United Kingdom
        • 209
    • Lancashire
      • Wigan, Lancashire, United Kingdom
        • 201
  • United States
    • Arizona
      • Mesa, Arizona, United States
        • 166
      • Paradise Valley, Arizona, United States
        • 154
      • Scottsdale, Arizona, United States
        • 118
    • Arkansas
      • Hot Springs, Arkansas, United States
        • 103
      • Jonesboro, Arkansas, United States
        • 125
    • California
      • Covina, California, United States
        • 127
      • La Jolla, California, United States
        • 148
      • Long Beach, California, United States
        • 184
      • Los Angeles, California, United States
        • 177
      • Palo Alto, California, United States
        • 104
      • Sacramento, California, United States
        • 149
      • San Diego, California, United States
        • 158
      • Santa Maria, California, United States
        • 129
      • Upland, California, United States
        • 164
      • Wildomar, California, United States
        • 107
    • Connecticut
      • Hamden, Connecticut, United States
        • 141
      • Norwalk, Connecticut, United States
        • 137
      • Trumbull, Connecticut, United States
        • 101
    • Delaware
      • Lewes, Delaware, United States
        • 111
    • Florida
      • Aventura, Florida, United States
        • 176
      • Daytona Beach, Florida, United States
        • 186
      • DeBary, Florida, United States
        • 151
      • Jupiter, Florida, United States
        • 114
      • Pinellas Park, Florida, United States
        • 183
      • Sarasota, Florida, United States
        • 178
      • South Miami, Florida, United States
        • 140
      • Tampa, Florida, United States
        • 157
    • Georgia
      • Gainesville, Georgia, United States
        • 130
      • Newnan, Georgia, United States
        • 162
      • Savannah, Georgia, United States
        • 153
      • Stockbridge, Georgia, United States
        • 113
    • Idaho
      • Idaho Falls, Idaho, United States
        • 116
    • Illinois
      • Moline, Illinois, United States
        • 160
      • Rock Island, Illinois, United States
        • 156
      • Springfield, Illinois, United States
        • 168
    • Iowa
      • Cedar Rapids, Iowa, United States
        • 133
    • Kansas
      • Kansas City, Kansas, United States
        • 172
    • Michigan
      • Saint Clair Shores, Michigan, United States
        • 185
    • Missouri
      • Saint Louis, Missouri, United States
        • 112
      • Saint Louis, Missouri, United States
        • 134
    • Nebraska
      • Lincoln, Nebraska, United States
        • 102
    • New Jersey
      • Freehold, New Jersey, United States
        • 171
      • New Brunswick, New Jersey, United States
        • 163
      • Toms River, New Jersey, United States
        • 152
    • New York
      • Brooklyn, New York, United States
        • 174
      • Rochester, New York, United States
        • 115
    • North Carolina
      • Belmont, North Carolina, United States
        • 109
      • Charlotte, North Carolina, United States
        • 170
    • Ohio
      • Cincinnati, Ohio, United States
        • 150
      • Columbus, Ohio, United States
        • 108
      • Dayton, Ohio, United States
        • 100
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 110
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • 165
      • Wexford, Pennsylvania, United States
        • 117
    • Tennessee
      • Nashville, Tennessee, United States
        • 105
      • Nashville, Tennessee, United States
        • 106
    • Texas
      • Amarillo, Texas, United States
        • 120
      • Austin, Texas, United States
        • 135
      • Dallas, Texas, United States
        • 128
      • Houston, Texas, United States
        • 126
      • Houston, Texas, United States
        • 132
      • Houston, Texas, United States
        • 138
      • Houston, Texas, United States
        • 181
      • Mesquite, Texas, United States
        • 145
      • Nassau Bay, Texas, United States
        • 143
      • San Antonio, Texas, United States
        • 122
      • Tomball, Texas, United States
        • 144
      • Victoria, Texas, United States
        • 142
    • Utah
      • Salt Lake City, Utah, United States
        • 121
    • Virginia
      • Chesapeake, Virginia, United States
        • 139
    • Washington
      • Seattle, Washington, United States
        • 119
      • Tacoma, Washington, United States
        • 175
    • West Virginia
      • Beckley, West Virginia, United States
        • 136
      • Clarksburg, West Virginia, United States
        • 167

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6 months prior to screening
  • Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to screening. Doses of 10 to < 12.5mg/week are allowed if there is documented intolerance
  • Have moderately to severely active rheumatoid arthritis disease with at least 6 tender and 6 swollen joints
  • CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte sedimentation rate of more than 28mm/hour
  • Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed TNF-blocker therapies within 2 years of screening

Exclusion Criteria:

  • Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing spondylitis
  • Wheelchair bound or bedridden.
  • Disease modifying antirheumatic drugs (DMARDs) other than MTX.
  • Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any time.
  • Treatment with other biologics within 4-24 weeks (depending on the biologic)
  • History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection
  • Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
  • Vaccinations (other than injectable influenza or pneumococcal) within 8 weeks prior to screening or plan to receive vaccines during the study
  • Concurrent or history of malignancy with the exception of nonmelanoma skin cancer successfully treated more than 2 years prior to screening or cervical cancer successfully treated more than 5 years prior to screening.
  • History of chronic alcohol abuse or drug addiction within the last 1 year or current drug addiction or use of illicit drugs.

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: Factorial Assignment
  • Masking: Double

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.
Experimental: CDP6038 60 mg sc every 2 weeks plus methotrexate
Biological: CDP6038
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
120 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
240 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
60 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
240 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
120 mg sc at Weeks 0, 4 and 8
Other: Placebo iv
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Experimental: CDP6038 60 mg sc every 4 weeks plus methotrexate
Biological: CDP6038
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
120 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
240 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
60 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
240 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
120 mg sc at Weeks 0, 4 and 8
Other: Placebo iv
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 2, 6 and 10
Experimental: CDP6038 120 mg sc every 2 weeks plus methotrexate
Biological: CDP6038
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
120 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
240 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
60 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
240 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
120 mg sc at Weeks 0, 4 and 8
Other: Placebo iv
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Experimental: CDP6038 120 mg sc every 4 weeks plus methotrexate
Biological: CDP6038
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
120 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
240 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
60 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
240 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
120 mg sc at Weeks 0, 4 and 8
Other: Placebo iv
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 2, 6 and 10
Experimental: CDP6038 240 mg sc every 2 weeks plus methotrexate
Biological: CDP6038
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
120 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
240 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
60 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
240 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
120 mg sc at Weeks 0, 4 and 8
Other: Placebo iv
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Experimental: CDP6038 240 mg sc every 4 weeks plus methotrexate
Biological: CDP6038
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
120 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
240 mg sc at Weeks 0, 2, 4 6, 8, and 10
Biological: CDP6038
60 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
240 mg sc at Weeks 0, 4 and 8
Biological: CDP6038
120 mg sc at Weeks 0, 4 and 8
Other: Placebo iv
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 2, 6 and 10
Active Comparator: Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 2, 6 and 10
Biological: Tocilizumab (Actemra or RoActemra)
8 mg/kg intravenously (iv) at Weeks 0, 4 and 8
Placebo Comparator: Placebo sc every 2 weeks plus methotrexate
Other: Placebo iv
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 2, 6 and 10
Placebo Comparator: Placebo sc every 4 weeks plus methotrexate
Other: Placebo iv
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 2, 6 and 10

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 (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo
Time Frame: Baseline, Week 12
Baseline, 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
Time Frame
American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms.
Time Frame: From Baseline to Week 12
From Baseline to Week 12
American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms.
Time Frame: From Baseline to Week 12
From Baseline to Week 12
American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms.
Time Frame: From Baseline to Week 12
From 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 Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

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.
November 1, 2010

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.
June 1, 2012

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.
June 1, 2012

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).
November 15, 2010

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.
November 16, 2010

First Posted (Estimated)

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 17, 2010

Study Record Updates

Last Update Posted (Actual)

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.
July 17, 2024

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.
July 16, 2024

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.
July 1, 2024

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.
  • RA0056
  • 2010-020839-39 (EudraCT Number)

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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