NCT00544154

Brief Summary

The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

October 15, 2007

Last Update Submit

September 3, 2013

Conditions

Arthritis, Rheumatoid

Keywords

CDP870Certolizumab pegol

Outcome Measures

Primary Outcomes (1)

  • American college of Rheumatolofy (ACR)-20 responder rate at Week 24

Secondary Outcomes (4)

  • Safety and tolerability

  • health outcomes measures

  • immunogenic profile of CDP870 plus methotrexate

  • systemic exposure of CDP870

Interventions

CDP870DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male/female, 18-75 years old, inclusive
  • diagnosis of adult-onset RA
  • had active disease
  • had received methotrexate
  • on a stable dose of folic acid

You may not qualify if:

  • contraindication for methotrexate or anti-TNF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, Davies O, Stahl HD, Alten R. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul;51(7):1226-34. doi: 10.1093/rheumatology/ker519. Epub 2012 Feb 16.

    PMID: 22344576RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 16, 2007

Study Start

October 1, 2002

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

September 4, 2013

Record last verified: 2009-09