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Long Term Effects of an Early Response to Certolizumab Pegol (CZP, Cimzia®) in Rheumatoid Arthritis (RA) Patients (RA-PROACTIVE)

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ClinicalTrials.gov Identifier: NCT01288287
Recruitment Status : Completed
First Posted : February 2, 2011
Results First Posted : June 27, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®) therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term clinical response at 18 months compared with a lack of clinical response at 12 weeks.

Condition or disease
Arthritis,Rheumatoid

Detailed Description:
Clinical response will be assessed by the percentage of patients achieving a reduction from Baseline in Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points, which is considered the minimum clinically important difference.
Study Design
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Study Type : Observational
Actual Enrollment : 149 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre, Non-interventional, Observational, Cohort Study to Evaluate the Long Term Clinical, Patient Reported and Health Care Resource Utilization Effects of an Early Response to Certolizumab Pegol (Cimzia®) in Rheumatoid Arthritis Patients in Daily Clinical Practice in the United Kingdom and Eire.
Study Start Date : July 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Week 12 Disease Activity Score (DAS) Responders
Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
Week 12 Disease Activity Score (DAS) Non-Responders
Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points [ Time Frame: Baseline (Week 0), 78 weeks ]

    DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:

    DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.

    DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity.



Secondary Outcome Measures :
  1. Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks [ Time Frame: Baseline (Week 0), 78 weeks ]

    DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:

    DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.

    DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity.


  2. Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline [ Time Frame: Baseline (Week 0), 78 weeks ]

    Percentage of patients achieving good, moderate, or no EULAR clinical response, where good response is defined as DAS28(ESR) ≤ 3.2 and decrease from baseline by > 1.2; moderate response is defined as achievement of one of the following:

    • DAS28(ESR) ≤ 3.2 and decrease from baseline > 0.6 and ≤ 1.2,
    • DAS28(ESR) > 3.2 and ≤ 5.1 and decrease from baseline > 0.6,
    • DAS28(ESR) > 5.1 and decrease from baseline > 1.2 Patients without a good or moderate response are considered to be non-responders.

  3. Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks [ Time Frame: Baseline (Week 0), 78 weeks ]

    RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state.

    A negative value in RADAI change from Baseline indicates an improvement from Baseline to 78 weeks.


  4. Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks [ Time Frame: Baseline (Week 0), 78 weeks ]
    HAQ-DI is a questionnaire which measures function and health-related quality of life. The final score range is 0-3, with higher scores denoting greater disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline to 78 weeks.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic
Criteria

Inclusion Criteria:

  • Informed consent is signed and dated
  • The patient is considered capable of and prepared to adhere to the study protocol procedures
  • The patient is prescribed CZP according to the Summary of Product Characteristics (SmPC) (UK and Eire) and National Institute of Clinical Excellence (NICE) (UK only) guidelines for anti tumor necrosis factor (TNF) α therapy for Rheumatoid Arthritis (RA).
  • The patient is screen-negative for tuberculosis
  • The patient is 18 years of age or above

Exclusion Criteria:

  • The patient has been exposed previously to biological disease modifying anti rheumatic drugs (DMARD) agents.
  • Patient has previously participated in this study or the patient has previously been assigned to treatment in a study of CZP or another biological agent used to treat RA.
  • Patient has participated in another study within the last 30 days
  • Patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study
  • Patient has inadequate literacy to understand and complete the questionnaires.
  • Contraindications stated in the SmPC
  • Patient is pregnant or breast feeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288287


Locations
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Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01288287    
Other Study ID Numbers: RA0042
First Posted: February 2, 2011    Key Record Dates
Results First Posted: June 27, 2016
Last Update Posted: September 16, 2016
Last Verified: August 2016
Keywords provided by UCB Pharma:
Certolizumab pegol
Cimzia®
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases