Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00160693
First received: September 6, 2005
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. Treatment will continue up to approval of a marketing application for this product.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Certolizumab Pegol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years [ Time Frame: From first dose of CZP up to 8 years ] [ Designated as safety issue: No ]

    An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

    First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo.


  • Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years [ Time Frame: From First Visit (Week 0 in this study) up to 8 years ] [ Designated as safety issue: No ]

    An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

    The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.



Secondary Outcome Measures:
  • Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52 [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]

    The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.


  • Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100 [ Time Frame: From Baseline to Week 100 ] [ Designated as safety issue: No ]

    The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.


  • Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160 [ Time Frame: From Baseline to Week 160 ] [ Designated as safety issue: No ]

    The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.


  • Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208 [ Time Frame: From Baseline to Week 208 ] [ Designated as safety issue: No ]

    The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.


  • Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256 [ Time Frame: From Baseline to Week 256 ] [ Designated as safety issue: No ]

    The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.


  • Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316 [ Time Frame: From Baseline to Week 316 ] [ Designated as safety issue: No ]

    The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.


  • Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit [ Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years ] [ Designated as safety issue: No ]
    The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

  • Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit [ Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years ] [ Designated as safety issue: No ]
    The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

  • Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit [ Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years ] [ Designated as safety issue: No ]
    The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit [ Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years ] [ Designated as safety issue: No ]
    The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.

  • Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years [ Time Frame: From First Visit (Week 0 in this study) up to 8 years ] [ Designated as safety issue: No ]
  • Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years [ Time Frame: From First Visit (Week 0 in this study) up to 8 years ] [ Designated as safety issue: No ]
    This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.


Enrollment: 402
Study Start Date: March 2003
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab Pegol Biological: Certolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Other Name: Cimzia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in CZP trial C87014 or C87011
  • If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
  • Must have provided written informed consent before undergoing any study procedures

Exclusion Criteria:

  • History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
  • Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
  • Any finding indicative of Tuberculosis at end of previous study
  • Known HIV infection
  • Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (> 2 times upper limit of normal)
  • Hemoglobin (Hgb) levels < 9 g/dL or Hematocrit < 30 %
  • Total White Blood Cell (WBC) count of < 3.0 x 100/L (< 3000/mm^3)
  • Platelet count < 100 x 100 L (100,000/mm^3)
  • Serum creatinine > 1.5 times upper limit of normal based on patient age and sex
  • Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
  • Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
  • Any other condition which the Principal Investigator judges would make patient unsuitable for study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160693

  Show 61 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00160693     History of Changes
Other Study ID Numbers: C87015, 2005-002617-21
Study First Received: September 6, 2005
Results First Received: February 15, 2012
Last Updated: June 4, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Rheumatoid Arthritis
America College of Rheumatology
Disease modifying anti-rheumatic drug
Certolizumab Pegol (CDP870)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Immunoglobulin Fab Fragments
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014