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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01242488

Run by

UCB Pharma

People needed

221

Starts

2010-11-01

Expected to finish

2012-06-01

Last updated by the study team

2024-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 154 — Paradise Valley, Arizona, United States
• 118 — Scottsdale, Arizona, United States
• 103 — Hot Springs, Arkansas, United States
• 125 — Jonesboro, Arkansas, United States
• 127 — Covina, California, United States
• 148 — La Jolla, California, United States
• 184 — Long Beach, California, United States
• 177 — Los Angeles, California, United States
• 104 — Palo Alto, California, United States
• 149 — Sacramento, California, United States
• 158 — San Diego, California, United States
• 129 — Santa Maria, California, United States
• 164 — Upland, California, United States
• 107 — Wildomar, California, United States
• 141 — Hamden, Connecticut, United States
• 137 — Norwalk, Connecticut, United States
• 101 — Trumbull, Connecticut, United States
• 111 — Lewes, Delaware, United States
• 176 — Aventura, Florida, United States
• 186 — Daytona Beach, Florida, United States
• 151 — DeBary, Florida, United States
• 114 — Jupiter, Florida, United States
• 183 — Pinellas Park, Florida, United States
• 178 — Sarasota, Florida, United States
• 166 — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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