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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CDP6038
CDP6038
CDP6038
Tocilizumab (Actemra or RoActemra)
CDP6038
CDP6038
CDP6038
Placebo sc
Placebo sc
Placebo iv
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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.

Sites / Locations

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  • 185
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  • 175
  • 136
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  • 401
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  • 208

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

CDP6038 60 mg sc every 2 weeks plus methotrexate

CDP6038 60 mg sc every 4 weeks plus methotrexate

CDP6038 120 mg sc every 2 weeks plus methotrexate

CDP6038 120 mg sc every 4 weeks plus methotrexate

CDP6038 240 mg sc every 2 weeks plus methotrexate

CDP6038 240 mg sc every 4 weeks plus methotrexate

Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate

Placebo sc every 2 weeks plus methotrexate

Placebo sc every 4 weeks plus methotrexate

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo

Secondary Outcome Measures

American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms.
American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms.
American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms.

Full Information

First Posted
November 15, 2010
Last Updated
August 26, 2014
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01242488
Brief Title
Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDP6038 60 mg sc every 2 weeks plus methotrexate
Arm Type
Experimental
Arm Title
CDP6038 60 mg sc every 4 weeks plus methotrexate
Arm Type
Experimental
Arm Title
CDP6038 120 mg sc every 2 weeks plus methotrexate
Arm Type
Experimental
Arm Title
CDP6038 120 mg sc every 4 weeks plus methotrexate
Arm Type
Experimental
Arm Title
CDP6038 240 mg sc every 2 weeks plus methotrexate
Arm Type
Experimental
Arm Title
CDP6038 240 mg sc every 4 weeks plus methotrexate
Arm Type
Experimental
Arm Title
Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate
Arm Type
Active Comparator
Arm Title
Placebo sc every 2 weeks plus methotrexate
Arm Type
Placebo Comparator
Arm Title
Placebo sc every 4 weeks plus methotrexate
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CDP6038
Intervention Description
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
Intervention Type
Biological
Intervention Name(s)
CDP6038
Intervention Description
120 mg sc at Weeks 0, 2, 4 6, 8, and 10
Intervention Type
Biological
Intervention Name(s)
CDP6038
Intervention Description
240 mg sc at Weeks 0, 2, 4 6, 8, and 10
Intervention Type
Biological
Intervention Name(s)
Tocilizumab (Actemra or RoActemra)
Intervention Description
8 mg/kg intravenously (iv) at Weeks 0, 4 and 8
Intervention Type
Biological
Intervention Name(s)
CDP6038
Intervention Description
60 mg sc at Weeks 0, 4 and 8
Intervention Type
Biological
Intervention Name(s)
CDP6038
Intervention Description
240 mg sc at Weeks 0, 4 and 8
Intervention Type
Biological
Intervention Name(s)
CDP6038
Intervention Description
120 mg sc at Weeks 0, 4 and 8
Intervention Type
Other
Intervention Name(s)
Placebo sc
Intervention Description
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
Intervention Type
Other
Intervention Name(s)
Placebo sc
Intervention Description
0.9% Sodium chloride for injection at Weeks 2, 6 and 10
Intervention Type
Other
Intervention Name(s)
Placebo iv
Intervention Description
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Primary Outcome Measure Information:
Title
Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms.
Time Frame
From Baseline to Week 12
Title
American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms.
Time Frame
From Baseline to Week 12
Title
American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms.
Time Frame
From Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
166
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
154
City
Paradise Valley
State/Province
Arizona
Country
United States
Facility Name
118
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
103
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
125
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
127
City
Covina
State/Province
California
Country
United States
Facility Name
148
City
La Jolla
State/Province
California
Country
United States
Facility Name
184
City
Long Beach
State/Province
California
Country
United States
Facility Name
177
City
Los Angeles
State/Province
California
Country
United States
Facility Name
104
City
Palo Alto
State/Province
California
Country
United States
Facility Name
149
City
Sacramento
State/Province
California
Country
United States
Facility Name
158
City
San Diego
State/Province
California
Country
United States
Facility Name
129
City
Santa Maria
State/Province
California
Country
United States
Facility Name
164
City
Upland
State/Province
California
Country
United States
Facility Name
107
City
Wildomar
State/Province
California
Country
United States
Facility Name
141
City
Hamden
State/Province
Connecticut
Country
United States
Facility Name
137
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
101
City
Trumbull
State/Province
Connecticut
Country
United States
Facility Name
111
City
Lewes
State/Province
Delaware
Country
United States
Facility Name
176
City
Aventura
State/Province
Florida
Country
United States
Facility Name
186
City
Daytona
State/Province
Florida
Country
United States
Facility Name
151
City
Debary
State/Province
Florida
Country
United States
Facility Name
114
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
183
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
178
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
140
City
South Miami
State/Province
Florida
Country
United States
Facility Name
157
City
Tampa
State/Province
Florida
Country
United States
Facility Name
130
City
Gainesville
State/Province
Georgia
Country
United States
Facility Name
162
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
153
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
113
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
116
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
160
City
Moline
State/Province
Illinois
Country
United States
Facility Name
156
City
Rock Island
State/Province
Illinois
Country
United States
Facility Name
168
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
133
City
Cedar Rapids
State/Province
Iowa
Country
United States
Facility Name
172
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
185
City
St. Clair Shores
State/Province
Michigan
Country
United States
Facility Name
112
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
134
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
102
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
171
City
Freehold
State/Province
New Jersey
Country
United States
Facility Name
163
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
152
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
174
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
115
City
Rochester
State/Province
New York
Country
United States
Facility Name
109
City
Belmont
State/Province
North Carolina
Country
United States
Facility Name
170
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
150
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
108
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
100
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
110
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
165
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
117
City
Wexford
State/Province
Pennsylvania
Country
United States
Facility Name
105
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
106
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
120
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
135
City
Austin
State/Province
Texas
Country
United States
Facility Name
128
City
Dallas
State/Province
Texas
Country
United States
Facility Name
126
City
Houston
State/Province
Texas
Country
United States
Facility Name
132
City
Houston
State/Province
Texas
Country
United States
Facility Name
138
City
Houston
State/Province
Texas
Country
United States
Facility Name
181
City
Houston
State/Province
Texas
Country
United States
Facility Name
145
City
Mesquite
State/Province
Texas
Country
United States
Facility Name
143
City
Nassau Bay
State/Province
Texas
Country
United States
Facility Name
122
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
144
City
Tomball
State/Province
Texas
Country
United States
Facility Name
142
City
Victoria
State/Province
Texas
Country
United States
Facility Name
121
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
139
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
119
City
Seattle
State/Province
Washington
Country
United States
Facility Name
175
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
136
City
Beckley
State/Province
West Virginia
Country
United States
Facility Name
167
City
Clarksburg
State/Province
West Virginia
Country
United States
Facility Name
401
City
Brussels
Country
Belgium
Facility Name
400
City
Liege
Country
Belgium
Facility Name
209
City
Torquay
State/Province
Devon
Country
United Kingdom
Facility Name
201
City
Wigan
State/Province
Lancashire
Country
United Kingdom
Facility Name
206
City
Essex
Country
United Kingdom
Facility Name
205
City
London
Country
United Kingdom
Facility Name
204
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
208
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24641941
Citation
Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, Bryson J, Duncan B, Zhu W, Pitzalis C, Durez P, Kretsos K. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Ann Rheum Dis. 2014 Sep;73(9):1607-15. doi: 10.1136/annrheumdis-2013-204760. Epub 2014 Mar 18.
Results Reference
derived

Learn more about this trial

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

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