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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

NCT01242488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2024-07-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States
  • Belgium
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01242488 on ClinicalTrials.gov