Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

NCT ID: NCT00674362

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-12-31

Brief Summary

To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis

Detailed Description

Treatment period starts with a 24-week, double blind, placebo-controlled, randomized period followed by an open label phase until week 52.

In the double blind phase eligible patients will be randomized via an Interactive Voice Response System (IVRS) in a 1:1 ratio to receive either certolizumab pegol (400 mg at Weeks 0, 2 and 4, followed by 200 mg every two weeks) or placebo up to and including Week 22. All patients will continue to receive their Disease Modifying AntiRheumatic Drugs (DMARDs) therapy established before study entry until Week 52. At Week 24, patients will not receive any injection but will be evaluated:

• Non-remitters at Week 24 (patients who did not achieve remission at both Week 20 and Week 24) will be discontinued from the study and may be given the opportunity to enter in an open-label follow-up trial, C87080 [NCT00843778], with certolizumab pegol.
• Remitters (i.e. patients who achieved remission as measured by Clinical Disease Activity Index (CDAI) at both Week 20 and Week 24) will stop their randomized treatment (certolizumab pegol or placebo) and be followed up until Week 52. Remitters who flare up (CDAI ≥11 confirmed at two consecutive visits four weeks apart) between Week 24 and Week 52 will be re-treated with the same dosing regimen of certolizumab pegol (3 administrations of 400mg, given every 2 weeks, followed by 200 mg given every other week) up to and including Week 50.

Remitters who flare up between Week 24 and Week 52 and complete 52-week study period will be allowed to enter open label follow up trial at Week 52.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Certolizumab pegol 200 mg (CDP870)

Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)

Group Type: EXPERIMENTAL

Certolizumab pegol

Intervention Type: BIOLOGICAL

Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)

Placebo

Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)

Interventions

Certolizumab pegol

Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)

Intervention Type: BIOLOGICAL

Placebo

Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)

Intervention Type: BIOLOGICAL

Other Intervention Names

CDP870; Cimzia

Eligibility Criteria

Inclusion Criteria

• Patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years

Exclusion Criteria

• All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient
• Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
• Patients must not have received any previous biological therapy for rheumatoid arthritis (RA)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Graz, , Austria

Vienna, , Austria

Nantes, , France

Paris, , France

Rennes, , France

Rouen, , France

Tours, , France

Bad Nauheim, , Germany

Berlin, , Germany

Erlangen, , Germany

Essen, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Heidelberg, , Germany

Herne, , Germany

Ratingen, , Germany

Vogelsang-Gom, , Germany

Würzburg, , Germany

Ferrara, , Italy

Padua, , Italy

Pavia, , Italy

Roma, , Italy

Bialystok, , Poland

Bydgoszcz, , Poland

Elblag, , Poland

Lublin, , Poland

Poznan, , Poland

Sopot, , Poland

Szczecin, , Poland

Torun, , Poland

Wroclaw, , Poland

Countries

Austria; France; Germany; Italy; Poland

References

Smolen JS, Emery P, Ferraccioli GF, Samborski W, Berenbaum F, Davies OR, Koetse W, Purcaru O, Bennett B, Burkhardt H. Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial. Ann Rheum Dis. 2015 May;74(5):843-50. doi: 10.1136/annrheumdis-2013-204632. Epub 2014 Jan 15.

Reference Type: DERIVED

PMID: 24431394 (View on PubMed)

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2007-000828-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C87076

Identifier Type: -

Identifier Source: org_study_id