Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01288287
First received: January 25, 2011
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Arthritis,Rheumatoid

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Disease Activity Score (DAS) Response at 18 months 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), 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score at 18 months [ Time Frame: Baseline (Week 0),18 months ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS)-based European League Against Rheumatoid Arthritis (EULAR) response at 18 months compared to Baseline [ Time Frame: Baseline (Week 0),18 months ] [ Designated as safety issue: No ]

    Proportion 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.

  • Change from Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) scores at 18 months [ Time Frame: Baseline (Week 0),18 months ] [ Designated as safety issue: No ]
    RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state.

  • Change from Baseline in Health Assessment Questionnaire-Disease Index (HAQ -DI) scores at 18 months [ Time Frame: Baseline (Week 0),18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 187
Study Start Date: July 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288287

Locations
Ireland
2
Cork, Ireland
United Kingdom
4
Durham, County Durham, United Kingdom
17
Poole, Dorset, United Kingdom
24
Eastbourne, East Sussex, United Kingdom
13
Southend, Essex, United Kingdom
11
Manchester, Greater Manchester, United Kingdom
12
Manchester, Greater Manchester, United Kingdom
6
Southampton, Hampshire, United Kingdom
20
Gillingham, Kent, United Kingdom
15
St. Helens, Lancashire, United Kingdom
10
Liverpool, Merseyside, United Kingdom
22
Ashford, Middlesex, United Kingdom
14
Abergavenny, Monmouthshire, United Kingdom
5
Bath, Somerset, United Kingdom
19
Burton, Staffordshire, United Kingdom
3
Chertsey, Surrey, United Kingdom
18
Birmingham, West Midlands, United Kingdom
16
Cannock, West Midlands, United Kingdom
9
Dudley, West Midlands, United Kingdom
1
York, Yorkshire, United Kingdom
7
Bridgend, United Kingdom
25
Cardiff, United Kingdom
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01288287     History of Changes
Other Study ID Numbers: RA0042
Study First Received: January 25, 2011
Last Updated: April 30, 2013
Health Authority: United Kingdom: Research Ethics Committee
Ireland: Ministry of Health

Keywords provided by UCB, Inc.:
Certolizumab pegol
Cimzia®

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

ClinicalTrials.gov processed this record on May 16, 2013