Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)

NCT00753454 | Completed Phase 3 Results

• 2 other identifiers: C870842007-005267-10
• Study Type: interventional
• Target: 168
• Locations: 2 countries
• Sites: 40

Brief Summary

The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Joint Disease; Arthritis; Certolizumab pegol; Cimzia

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period

  A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection.

  From Entry Visit up to approximately 60 weeks

• Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period

  A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection.

  From Entry Visit up to approximately 60 weeks

• Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period

  A Serious Adverse Event is any untoward medical occurrence that at any dose * results in death, * is life threatening, * requires in-patient hospitalization or prolongation of existing hospitalization, * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect

  From Entry Visit up to approximately 60 weeks

Secondary Outcomes (23)

• Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit

  Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

• Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit

  Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

• Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit

  Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

• Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit

  Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

• Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit

  Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Study Arms (1)

CDP870

EXPERIMENTAL

Patients having completed the week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of RA in the patient's country or region (or until further notice from UCB).

Drug: Certolizumab pegol

Interventions

Certolizumab pegol DRUG

Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 \& Week 4, followed by 200 mg every 2 weeks).

Also known as: Cimzia

CDP870

Eligibility Criteria

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

You may qualify if:

• Patients must be able to understand the written Informed Consent Form (ICF)
• Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
• Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
• Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
• Patients must be willing to comply with protocol

You may not qualify if:

• Patients must not have a diagnosis of any other inflammatory Arthritis
• Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
• Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (40)

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Huntsville, Alabama, United States

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Paradise Valley, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Palm Desert, California, United States

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San Diego, California, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Melbourne, Florida, United States

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Sarasota, Florida, United States

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Morton Grove, Illinois, United States

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Vernon Hills, Illinois, United States

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Lexington, Kentucky, United States

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Haverhill, Massachusetts, United States

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Worcester, Massachusetts, United States

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Rochester, Minnesota, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Albany, New York, United States

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Mineola, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Monroe, North Carolina, United States

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Wilmington, North Carolina, United States

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Norman, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. Catharines, Ontario, Canada

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Toronto, Ontario, Canada

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Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid; Joint Diseases; Arthritis

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

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: UCB (Study Director)
• Organization: UCB Clinical Trial Call Center

1-887-822-9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: September 16, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 1, 2018
• Results First Posted: June 14, 2012

Record last verified: 2012-07

Locations

US (36); CA (4)