Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)
(Dose Flex II Trial)

Recruiting in Palo Alto (17 mi)

+39 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UCB Pharma

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).

Eligibility Criteria

Inclusion Criteria

Patients must be able to understand the written Informed Consent Form (ICF)

Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare

Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)

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Treatment Details

Interventions

Certolizumab pegol (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: CDP870Experimental Treatment1 Intervention

Patients having completed the week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of RA in the patient's country or region (or until further notice from UCB).

Certolizumab pegol is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Cimzia for: