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

NCT01147341 | Completed Phase 4 Results

• 1 other identifier: CERT-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 12

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; anti-TNF therapy

Outcome Measures

Primary Outcomes (2)

• 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

  The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI \> 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI \> 10 and ≤ 22; High Disease Activity: CDAI \> 22. A CDAI reduction of 6.5 represents moderate improvement.

  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

  ACR20 responders are subjects with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale(VAS). HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

  From Baseline to Week 12

Secondary Outcomes (4)

• 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

Other Outcomes (6)

• 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

  Baseline to Week 24

• Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group

  Baseline to Week 24

• Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group

  Baseline to Week 24

Study Arms (2)

placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

active treatment with Cimzia

ACTIVE COMPARATOR

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.

Drug: Cimzia

Interventions

Cimzia DRUG

prefilled 200mg Cimzia syringe SC q 2 weeks

Also known as: 1 ml liquid product containing 200mg of Certolizumab Pegol

active treatment with Cimzia

Placebo DRUG

prefilled saline syringe

Also known as: 1 ml Sodium Cloride 0.9%

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Schiff, MD: lead
• UCB Pharma: collaborator

Study Sites (12)

Rheumatology Associates of N. Alabama

Huntsville, Alabama, 35801, United States

Location

Sun Valley Arthritis Center, Ltd.

Peoria, Arizona, 85381, United States

Location

Arizona Arthritis and Rhematolgy Research

Phoenix, Arizona, 85037, United States

Location

Sarasota Arthritis Research Center

Sarasota, Florida, 34239, United States

Location

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516, United States

Location

Westroads Medical Group

Omaha, Nebraska, 68114, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

Buffalo Rheumatology

Orchard Park, New York, 14127, United States

Location

Rheumatology Associates of Long Island

Smithtown, New York, 11787, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Mountain State Clinical Research

Clarksburg, West Virginia, 26301, United States

Location

Rheumatology and Immunotherapy Center

Oak Creek, Wisconsin, 53154, United States

Location

Related Publications (1)

• 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.

  PMID: 24972708 RESULT

Related Links

• EULAR 2012 SAT0144
• Schiff,m

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Michael schiff
• Organization: michael schiff

michael.schiff@me.com

303 773 8429

Study Officials

• Michael H Schiff, MD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 9, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-05

Locations

US (12)