Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia

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

Sponsors

Lead Sponsor: Michael Schiff, MD

Collaborator: UCB Pharma

Source Schiff, Michael, M.D.
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).

Overall Status Completed
Start Date July 2010
Completion Date January 2012
Primary Completion Date January 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Baseline to week 12
Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group From Baseline to Week 12
Secondary Outcome
Measure Time Frame
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 Baseline to Week 12
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) Baseline to Week 12
Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group Baseline to week 12
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 Baseline to week 12
Enrollment 37
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cimzia

Description: prefilled 200mg Cimzia syringe SC q 2 weeks

Arm Group Label: active treatment with Cimzia

Other Name: 1 ml liquid product containing 200mg of Certolizumab Pegol

Intervention Type: Drug

Intervention Name: Placebo

Description: prefilled saline syringe

Arm Group Label: placebo

Other Name: 1 ml Sodium Cloride 0.9%

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role
Michael H Schiff, MD Study Director
Location
Facility:
Rheumatology Associates of N. Alabama | Huntsville, Alabama, 35801, United States
Sun Valley Arthritis Center, Ltd. | Peoria, Arizona, 85381, United States
Arizona Arthritis and Rhematolgy Research | Phoenix, Arizona, 85037, United States
Sarasota Arthritis Research Center | Sarasota, Florida, 34239, United States
Physician Research Collaboration, LLC | Lincoln, Nebraska, 68516, United States
Westroads Medical Group | Omaha, Nebraska, 68114, United States
Morristown Memorial Hospital | Morristown, New Jersey, 07960, United States
Buffalo Rheumatology | Orchard Park, New York, 14127, United States
Rheumatology Associates of Long Island | Smithtown, New York, 11787, United States
Altoona Center for Clinical Research | Duncansville, Pennsylvania, 16635, United States
Mountain State Clinical Research | Clarksburg, West Virginia, 26301, United States
Rheumatology and Immunotherapy Center | Oak Creek, Wisconsin, 53154, United States
Location Countries

United States

Verification Date

May 2014

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Schiff, Michael, M.D.

Investigator Full Name: Michael Schiff, MD

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: placebo

Type: Placebo Comparator

Description: Placebo (0.9% sodium chloride) given as 2 subcutaneous (sc) injections at weeks 0, 2, and 4, followed y 1 sc injection given an weeks 6, 8, and 10. At week 12 subjects entered the open label phase. Subjects received 400 mg of Cimzia (CZP) given as two 200 mg subcutaneous (sc) injections at weeks 12,14 and 16, followed by 1 sc injection at weeks 18, 20, and 22.

Label: active treatment with Cimzia

Type: Active Comparator

Description: 400 mg of Cimzia (CZP) given as two 200 mg subcutaneous (sc) injections at weeks 0, 2, and 4, followed by 1 sc injection at weeks 6, 8, and 10. At week 12 subjects entered the open label phase. Subjects received 400 mg of Cimzia (CZP) given as two 200 mg subcutaneous (sc) injections at weeks 12,14 and 16, followed by 1 sc injection at weeks 18, 20, and 22.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov