Clinical trial NCT00674362: Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
Official title: A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Moderate to Low Disease activity
Certolizumab pegol
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24
timeFrame: Week 20 and Week 24
Secondary outcomes:
measure: 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24
timeFrame: Week 20 and Week 24
measure: Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24
timeFrame: Week 20 and Week 24
measure: Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits
timeFrame: Week 24 up to Week 52
measure: Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits
timeFrame: Week 24 up to Week 52
measure: Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits
timeFrame: Week 24 up to Week 52
measure: American College of Rheumatology 20% (ACR20) Response at Week 24
timeFrame: Baseline, Week 24
measure: American College of Rheumatology 50% (ACR50) Response at Week 24
timeFrame: Baseline, Week 24
measure: American College of Rheumatology 70% (ACR70) Response at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Fatigue Assessment Scale at Week 24
timeFrame: Baseline, Week 24
Other outcomes:
measure: Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits
timeFrame: From Week 24 up to Week 52
measure: Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24
timeFrame: Week 24
measure: Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24
timeFrame: Week 24
measure: Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24
timeFrame: Week 24
measure: Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24
timeFrame: Week 24
measure: Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24
timeFrame: Week 24
measure: Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24
timeFrame: Week 24
Locations:
city: Graz
country: Austria
city: Wien
country: Austria
city: Nantes
country: France
city: Paris
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Tours
country: France
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Herne
country: Germany
city: Ratingen
country: Germany
city: Vogelsang-Gom
country: Germany
city: Wurzburg
country: Germany
city: Ferrara
country: Italy
city: Padova
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Elblag
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Sopot
country: Poland
city: Szczecin
country: Poland
city: Torun
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.