Dosing Flexibility Study in Patients With Rheumatoid Arthritis (DoseFlex)

UCB

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Other: Placebo; Drug: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00580840

C87077

2007-005288-86 (EudraCT Number)

Details and patient eligibility

About

During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.

Full description

Subjects with a stable methotrexate (MTX) dose enter the run-in period in which certolizumab pegol (CZP) will be administered at a dose of 400 mg (2 injections) at Weeks 0, 2, and 4 and at a dose of 200 mg with placebo (1 injection placebo, 1 injection CZP) at Weeks 6, 8, 10, 12, 14 and 16. The dose of MTX should be stable for at least 2 months prior to the Baseline visit and will remain stable throughout the trial, unless there is a need to reduce the dose for reasons of toxicity.

At the Week 18 visit, subjects who were ACR20 (American College of Rheumatology 20% Improvement) responders at Week 16 will be randomized in a double-blinded way to receive either 400 mg CZP given every 4 weeks and placebo given every 4 weeks given as two injections (alternating CZP and placebo every two weeks) plus MTX, 200 mg CZP and placebo administered every 2 weeks (one injection of each) plus MTX, or Placebo administered as two injections every 2 weeks plus MTX. Non-responders will be withdrawn from the study.

Enrollment: 333 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with established adult rheumatoid arthritis currently on Methotrexate for at least 3 months

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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333 participants in 3 patient groups, including a placebo group

Certolizumab pegol 400 mg and placebo

Active Comparator group

Description:

400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)

Treatment:

Other: Placebo

Drug: Certolizumab pegol

Drug: Certolizumab pegol

Certolizumab pegol 200 mg and placebo

Experimental group

Description:

200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)

Treatment:

Other: Placebo

Drug: Certolizumab pegol

Drug: Certolizumab pegol

Placebo

Placebo Comparator group

Description:

Placebo administered as two injections every 2 weeks

Treatment:

Other: Placebo