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

August 26, 2014 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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

221

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

  • 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, 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
      • St. Clair Shores, Michigan, United States
        • 185
    • Missouri
      • St. Louis, Missouri, United States
        • 112
      • St. 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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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

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

UCB Pharma

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

November 1, 2010

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 16, 2010

First Posted (ESTIMATE)

November 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 27, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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