Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (CERTAIN 2)

UCB

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Certolizumab Pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00843778

C87080

2007-000830-38 (EudraCT Number)

Details and patient eligibility

About

To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)

Full description

This is a Phase IIIB, multi-centre, open-label, follow-up study to study C87076 [NCT00674362] designed to continue to assess the safety and efficacy of Certolizumab Pegol.

Two different population will enter the study from C87076 [NCT00674362] and will be treated with Certolizumab Pegol every two weeks until it is commercially available for the indication of Rheumatoid Arthritis (RA) in the subject's country or region or until further notice from UCB:

Population 1: Are those subjects who failed to achieve remission at Week 20 and/or Week 24 and who completed the Week 24 assessment of study C86076 [NCT00674362].The Week 24 assessment (visit 14) of C87076 [NCT00674362] will also be the entry assessment (visit 1) for C87080. The subjects will receive Certolizumab Pegol 200 mg every two weeks. No induction period will be applied to ensure the blinding of study C87076 [NCT00674362].

Population 2: Are those subjects who achieved remission at both Week 20 and Week 24, flared up between Week 24 and Week 52 and completed the Week 52 assessment in study C87076 [NCT00674362]. The Week 52 assessment (visit 26) of C87076 [NCT00674362] will also be the entry assessment (visit 1) for C87080.

Subjects who flared prior to Week 48 in the C87076 [NCT00674362] study will receive Certolizumab Pegol 200 mg every two weeks in the C87080 study.

Those who flared at Week 48 or Week 52, will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with established adult rheumatoid arthritis on Disease Modifying Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and:
• either failed to achieve remission after 6 months of study treatment
• or flared after the 6 months of study treatment and completed the study (C87076 [NCT00674362])

Exclusion criteria

• All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
• Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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131 participants in 1 patient group

Certolizumab Pegol

Experimental group

Description:

Certolizumab Pegol 200 mg every two weeks at the hospital by a nurse. Certolizumab Pegol 200 mg every two weeks at the patient's home done by patient (self-injection).

Treatment:

Biological: Certolizumab Pegol