NCT01197066

Brief Summary

This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_3 rheumatoid-arthritis

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

March 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2010

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 10, 2022

Status Verified

March 1, 2017

Enrollment Period

6.7 years

First QC Date

March 17, 2010

Last Update Submit

June 7, 2022

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters.

    Treatment will continue until the drug is commercially available in the country.

    Up to 7 years

Secondary Outcomes (4)

  • To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.

    Up to 7 years

  • Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36)

    Up to 7 years

  • To assess the achievement of clinical remission measured by DAS28.

    Up to 7 years

  • The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).

    Up to 7 years

Study Arms (1)

Certolizumab Pegol

OTHER

Single Arm

Drug: Certolizumab Pegol

Interventions

Certolizumab PegolDRUG

Certolizumab Pegol 200mg

Also known as: CDP870, CIMZIA, Perstymab
Certolizumab Pegol

Eligibility Criteria

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

You may qualify if:

  • Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
  • Have a clear chest X-ray at the Entry visit
  • Negative urine pregnancy test at the Entry
  • Continue treatment on methotrexate

You may not qualify if:

  • Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
  • Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
  • At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
  • NYHA (New York Heart Association) Class III or IV congestive heart failure
  • Current or history of tuberculosis
  • History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
  • History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
  • High risk of infection
  • Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • YoungMo Kang, MD, PhD

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2010

First Posted

September 9, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 10, 2022

Record last verified: 2017-03