Musculoskeletal Diseases

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Immune System Diseases

Arthritis

Necrosis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

All Drugs and Chemicals

Pharmaceutical Solutions

Anti-Inflammatory Agents

Antibodies

Antibodies, Monoclonal

Tumor Necrosis Factor Inhibitors

Immunoglobulins

Injections administered at week 0, 2, 4, 6, 8 and 10

Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10

Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10

Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10

Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10

Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10

Placebo solution for injection, administered as subcutaneous injections

Placebo

Olokizumab 60 mg solution for injection, administered as subcutaneous injections

Olokizumab 60 mg

Olokizumab 120 mg solution for injection, administered as subcutaneous injections

Olokizumab 120 mg

Olokizumab 240 mg solution for injection, administered as subcutaneous injections

Olokizumab 240 mg

UCB Clinical Trial Call Center

The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.

Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy

Number of subjects who achieve ACR 20 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

Number of subjects who achieve ACR 50 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

Number of subjects who achieve ACR 70 will be calculated at week 12. The calculations is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

UCB Japan Co. Ltd.

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Methotrexate

60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10

CDP6038

8 mg/kg intravenously (iv) at Weeks 0, 4 and 8

Tocilizumab (Actemra or RoActemra)

0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10

Placebo sc

0.9% Sodium chloride for injection at Weeks 2, 6 and 10

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

Placebo iv

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy	NCT01463059	Rheumatoid Arth...	Placebo Olokizumab 60 m... Olokizumab 120 ... Olokizumab 240 ...	20 Years -	UCB Pharma
Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy	NCT01242488	Rheumatoid Arth...	CDP6038 CDP6038 CDP6038 Tocilizumab (Ac... CDP6038 CDP6038 CDP6038 Placebo sc Placebo sc Placebo iv	18 Years -	UCB Pharma
Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy	NCT01463059	Rheumatoid Arth...	Placebo Olokizumab 60 m... Olokizumab 120 ... Olokizumab 240 ...	20 Years -	UCB Pharma

Spots Global Cancer Trial Database for cdp6038

Every month we try and update this database with for cdp6038 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cdp6038

Every month we try and update this database with for cdp6038 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cdp6038 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.