Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

A Phase Ⅲ Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01197066

Enrollment

110

Registered

2010-09-09

Start date

2010-03-31

Completion date

2016-11-30

Last updated

2022-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGCertolizumab Pegol

Certolizumab Pegol 200mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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.	Up to 7 years	Treatment will continue until the drug is commercially available in the country.

Secondary

Measure	Time frame	Description
To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.	Up to 7 years	Treatment will continue until the drug is commercially available in the country.
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	Treatment will continue until the drug is commercially available in the country.
To assess the achievement of clinical remission measured by DAS28.	Up to 7 years	Treatment will continue until the drug is commercially available in the country.
The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).	Up to 7 years	Treatment will continue until the drug is commercially available in the country.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026