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

NCT ID: NCT01147341

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-01-31

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).

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

prefilled saline syringe

active treatment with Cimzia

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.

Group Type: ACTIVE_COMPARATOR

Cimzia

Intervention Type: DRUG

prefilled 200mg Cimzia syringe SC q 2 weeks

Interventions

Cimzia

prefilled 200mg Cimzia syringe SC q 2 weeks

Intervention Type: DRUG

Placebo

prefilled saline syringe

Intervention Type: DRUG

Other Intervention Names

1 ml liquid product containing 200mg of Certolizumab Pegol; 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Michael Schiff, MD

INDIV

Sponsor Role: lead

Responsible Party

Michael Schiff, MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael H Schiff, MD

Role: STUDY_DIRECTOR

Locations

Rheumatology Associates of N. Alabama

Huntsville, Alabama, United States

Sun Valley Arthritis Center, Ltd.

Peoria, Arizona, United States

Arizona Arthritis and Rhematolgy Research

Phoenix, Arizona, United States

Sarasota Arthritis Research Center

Sarasota, Florida, United States

Physician Research Collaboration, LLC

Lincoln, Nebraska, United States

Westroads Medical Group

Omaha, Nebraska, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Buffalo Rheumatology

Orchard Park, New York, United States

Rheumatology Associates of Long Island

Smithtown, New York, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Mountain State Clinical Research

Clarksburg, West Virginia, United States

Rheumatology and Immunotherapy Center

Oak Creek, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24972708 (View on PubMed)

Related Links

http://www.EULAR.org

EULAR 2012 SAT0144

http://www.rheumatology.org

Schiff,m

Other Identifiers

CERT-001

Identifier Type: -

Identifier Source: org_study_id