Clinical trial NCT00580840: Dosing Flexibility Study in Patients With Rheumatoid Arthritis
Official title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Joint Disease
Arthritis
Certolizumab pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 333
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: 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.

Detailed 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 Non-responders will be withdrawn from the study.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
Secondary outcomes:
measure: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients
timeFrame: Week 16
measure: SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients
timeFrame: Week 16
measure: CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients
timeFrame: Week 16
measure: Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18
timeFrame: Week 34
measure: SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18
timeFrame: Week 34
measure: CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18
timeFrame: Week 34
measure: Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18.
timeFrame: Week 18 up to Week 34
Other outcomes:
measure: Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients
timeFrame: Baseline, Week 16
measure: Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in PhGADA (Physician's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
measure: Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18
timeFrame: Baseline, Week 34
Locations:
city: Huntsville
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Gilbert
country: United States
state: Arizona
city: Paradise Valley
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Huntington Beach
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Bogart
country: United States
state: Georgia
city: Morton Grove
country: United States
state: Illinois
city: Vernon Hills
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Portland
country: United States
state: Maine
city: Haverhill
country: United States
state: Massachusetts
city: Pittsfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: Albany
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Monroe
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Simpsonville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Vancouver
country: United States
state: Washington
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Burlington
country: Canada
state: Ontario
city: St. Catherine's
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Bobigny
country: France
city: Le Havre
country: France
city: Lille
country: France
city: Limoges
country: France
city: Montivilliers
country: France
city: Nice
country: France
city: Paris
country: France
city: Perpigan
country: France
city: Saint-Etienne
country: France
Study officials:
affiliation: +1 877 822 9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, Staelens F, Koetse W, Bertin P. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):151-60. doi: 10.1002/acr.22496.