NCT01242488

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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	Tocilizumab (Actemra or RoActemra)	8 mg/kg intravenously (iv) at Weeks 0, 4 and 8
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 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
OTHER	Placebo iv	0.9% Sodium chloride for injection at Weeks 0, 4 and 8

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-11-17
• Last updated: 2024-07-17

Locations

82 sites across 3 countries: United States, Belgium, United Kingdom