Clinical trial NCT01147341: Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia
Official title: Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response By Switching to Certolizumab Pegol (Cimzia)? A Phase IV, Randomized, Multi-Center, Double-Blind, Twelve-Week Study Followed by a 12-Week Open-Label Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
anti-TNF therapy
Lead sponsor: Schiff, Michael, M.D.
Sponsor class: INDIV
Collaborators: name: UCB Pharma
First posted: 2010-06-22
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of the study is to determine if Cimzia is safe and effective in subjects who have received previous treatment with a TNF-alpha inhibitor other than Cimzia.

Detailed description: This is a Phase IV, randomized, multi-center, double-blind, parallel-group 12-week study of Cimzia with concomitant methotrexate (MTX) or other DMARD compared to MTX or other DMARD alone in patients with an inadequate secondary therapeutic response to a TNF-alpha inhibitor as defined above and active rheumatoid arthritis (RA) followed by a 12-week open-label phase with concomitant MTX or other DMARD and Cimzia.

Subjects must washout from the previous TNF inhibitor for at least 4 weeks prior to the baseline visit. Subjects unable to tolerate MTX must have been on a stable dose of another non-biologic DMARD for at least 3 months. Subjects' diagnosis of RA must be based on the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis.

Subjects will be screened for eligibility and, up to 28 days later, at the baseline visit, randomized to one of two treatment groups (2:1): Cimzia or placebo (in addition to concomitant MTX or other DMARD). All subjects will continue MTX/other DMARD at the same dose utilized prior to study entry.

After the Week 12 study visit, all subjects will have the opportunity to continue in the study on open-label Cimzia treatment (using an induction regimen for all subjects, regardless of their treatment in the blinded phase).

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of RA at least 6 months
* Have received treatment with a TNF-alpha inhibitor
* Be receiving Methotrexate (with folic acid)at a dose of at least 10mg/week or another non-biologic DMARD if Methotrexate intolerant \*Have at least 6 tender joint and 6 swollen joints\*
* Have an CRP greater than or equal to ULN
* Availability of a chest x-ray that shows no evidence of active TB or infection

Exclusion Criteria:

* Prior exposure to Cimzia
* Prior treatment with B-cell depleting therapy
* No significant response to previous TNF inhibitor
* Congestive heart failure
* Clinically abnormal laboratory tests
* History of cancer
* Active TB

Primary outcomes:
measure: Proportion of Subjects Achieving a Clinical Disease Activity Index (CDAI) Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 12
timeFrame: Baseline to week 12
measure: Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group at Week 12
timeFrame: Baseline to Week 12
measure: Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)
timeFrame: Baseline to Week 12
measure: Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
timeFrame: Baseline to week 12
measure: Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 12
timeFrame: Baseline to week 12
Other outcomes:
measure: Proportion of Subjects Achieving a CDAI Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 24
timeFrame: Baseline to Week 24
measure: Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
timeFrame: Baseline to Week 24
measure: Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
timeFrame: Baseline to Week 24
measure: Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)
timeFrame: Baseline to Week 24
measure: Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group
timeFrame: Baseline to Week 24
measure: Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 24
timeFrame: Baseline to Week 24
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of N. Alabama
state: Alabama
city: Peoria
country: United States
facility: Sun Valley Arthritis Center, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis and Rhematolgy Research
state: Arizona
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Omaha
country: United States
facility: Westroads Medical Group
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Orchard Park
country: United States
facility: Buffalo Rheumatology
state: New York
city: Smithtown
country: United States
facility: Rheumatology Associates of Long Island
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Clarksburg
country: United States
facility: Mountain State Clinical Research
state: West Virginia
city: Oak Creek
country: United States
facility: Rheumatology and Immunotherapy Center
state: Wisconsin
Study officials:
name: Michael H Schiff, MD
role: STUDY_DIRECTOR
References:
citation: Schiff MH, von Kempis J, Goldblum R, Tesser JR, Mueller RB. Rheumatoid arthritis secondary non-responders to TNF can attain an efficacious and safe response by switching to certolizumab pegol: a phase IV, randomised, multicentre, double-blind, 12-week study, followed by a 12-week open-label phase. Ann Rheum Dis. 2014 Dec;73(12):2174-7. doi: 10.1136/annrheumdis-2014-205325. Epub 2014 Jun 27.