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Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

NCT01500278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 915

Last updated 2018-07-31

Study results available
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Summary

This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.

Conditions

Interventions

BIOLOGICAL

Certolizumab Pegol (CZP)

* Active substance: an injectable volume of 1 ml solution for injection CZP * Pharmaceutical form: prefilled syringes CZP * Concentration: 200 mg/ml CZP * Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.

BIOLOGICAL

Adalimumab (ADA)

* Active substance: an injectable volume of 0.8 ml solution for injection ADA * Pharmaceutical form: prefilled syringes ADA * Concentration: 40 mg/0.8 ml ADA * Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.

DRUG

Methotrexate (MTX)

* Active substance: Methotrexate * Pharmaceutical form: oral tablet * Concentration: 15-25 mg/week * Route of Administration: MTX orally

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • UCB Pharma SA

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Monaco
  • Poland
  • Portugal
  • Romania
  • Spain
  • Switzerland
  • 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 NCT01500278 on ClinicalTrials.gov