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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Baseline, Week 12

Safety Issue:

No

Principal Investigator

UCB Clinical Trial Call Center

Investigator Role:

Study Director

Investigator Affiliation:

+1 877 822 9493 (UCB)

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

RA0056

NCT ID:

NCT01242488

Start Date:

November 2010

Completion Date:

June 2012

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid Arthritis
  • CDP6038
  • Interleukin-6
  • Tocilizumab
  • Arthritis
  • Arthritis, Rheumatoid

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166 Mesa, Arizona  
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158 San Diego, California  
129 Santa Maria, California  
164 Upland, California  
107 Wildomar, California  
141 Hamden, Connecticut  
137 Norwalk, Connecticut  
101 Trumbull, Connecticut  
111 Lewes, Delaware  
176 Aventura, Florida  
186 Daytona, Florida  
151 Debary, Florida  
114 Jupiter, Florida  
183 Pinellas Park, Florida  
178 Sarasota, Florida  
140 South Miami, Florida  
157 Tampa, Florida  
130 Gainesville, Georgia  
162 Newnan, Georgia  
153 Savannah, Georgia  
113 Stockbridge, Georgia  
116 Idaho Falls, Idaho  
160 Moline, Illinois  
156 Rock Island, Illinois  
168 Springfield, Illinois  
133 Cedar Rapids, Iowa  
172 Kansas City, Kansas  
185 St. Clair Shores, Michigan  
112 St. Louis, Missouri  
134 St. Louis, Missouri  
102 Lincoln, Nebraska  
171 Freehold, New Jersey  
163 New Brunswick, New Jersey  
152 Toms River, New Jersey  
174 Brooklyn, New York  
115 Rochester, New York  
109 Belmont, North Carolina  
170 Charlotte, North Carolina  
150 Cincinnati, Ohio  
108 Columbus, Ohio  
100 Dayton, Ohio  
110 Oklahoma City, Oklahoma  
165 Duncansville, Pennsylvania  
117 Wexford, Pennsylvania  
105 Nashville, Tennessee  
106 Nashville, Tennessee  
120 Amarillo, Texas  
135 Austin, Texas  
128 Dallas, Texas  
126 Houston, Texas  
132 Houston, Texas  
138 Houston, Texas  
181 Houston, Texas  
145 Mesquite, Texas  
143 Nassau Bay, Texas  
122 San Antonio, Texas  
144 Tomball, Texas  
142 Victoria, Texas  
121 Salt Lake City, Utah  
139 Chesapeake, Virginia  
119 Seattle, Washington  
175 Tacoma, Washington  
136 Beckley, West Virginia  
167 Clarksburg, West Virginia