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A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis (C-early)

This study is currently recruiting participants.
Verified April 2013 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01519791
First received: January 19, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
 Biological: Certolizumab Pegol + Methotrexate (MTX)
Biological: Placebo + Methotrexate (MTX)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Percentage of subjects in sustained remission at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Sustained remission is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at both Weeks 40 and 52.


Secondary Outcome Measures:
  • Percentage of subjects in sustained Low Disease Activity (LDA) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) ≤ 3.2 at both Weeks 40 and 52.

  • Change from Baseline in modified Total Sharp Score (mTSS) to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
    Van der Heijde modified Total Sharp Score (mTSS).

  • Percentage of subjects with radiographic non-progression from Baseline to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
    Radiographic non-progression is defined as change in mTSS ≤ 0.5.

  • Change from Baseline in the joint erosion score to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
  • Change from Baseline in the joint narrowing score to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
  • Percentage of subjects meeting the American College of Rheumatology 20% response criteria (ACR20) at Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
    The assessments are based on a 20% or greater improvement from Baseline 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 Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
    The assessments are based on a 50% or greater improvement from Baseline 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 Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
    The assessments are based on a 70% or greater improvement from Baseline 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).

  • Percentage of subjects meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) remission criteria at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

    The ACR/EULAR 2011 remission criteria is defined as:

    Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1, C-reactive protein (CRP) ≤ 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.


  • Percentage of subjects with Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of subjects with Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of subjects with Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of subjects meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) remission criteria simplified for clinical practice at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

    The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:

    Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.


  • Percentage of subjects achieving a good or moderate European League Against Rheumatism (EULAR) response at Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]

    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.

  • Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinical Disease Activity Index (CDAI) to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
  • Change from Baseline in Simplified Disease Activity Index (SDAI) to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
  • Percentage of subjects with a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

    The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.

    The total score ranges from 0 to 3 with lower scores meaning lower disability.


  • Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]

    The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.

    The total score ranges from 0 to 3 with lower scores meaning lower disability.


  • Change from Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) total score to Week 52 [ Time Frame: From Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
    BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue).

  • Number of work days missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Number of work days missed in the last month.

  • Number of work days with reduced productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Number of work days with reduced productivity in the last month.

  • Interference with work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).

  • Number of days with no household work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Number of days with no household work in the last month.

  • Number of days with reduced household work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Number of days with reduced household work productivity in the last month.

  • Number of days with hired outside help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Number of days with hired outside help in the last month.

  • Number of days missed of family/social/leisure activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Number of days missed of family/social/leisure activities in the last month.

  • Interference with household work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).

  • Percentage of subjects achieving Low Disease Activity (LDA) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2.


Estimated Enrollment: 800
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab Pegol + Methotrexate Biological: Certolizumab Pegol + Methotrexate (MTX)

Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.

Injections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50.

The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8.

Other Names:
  • Cimzia
  • CZP
  • MTX
Placebo Comparator: Placebo + Methotrexate Biological: Placebo + Methotrexate (MTX)

2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.

The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8.

Other Name: MTX

  Eligibility

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

Inclusion Criteria:

  • Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit
  • Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP)
  • Active RA disease
  • DMARD-naïve
  • Subject is naïve to RA related biologics

Exclusion Criteria:

  • A diagnosis of any other inflammatory Arthritis
  • History of infected joint prosthesis, or other significant infection and other serious medical condition
  • Known Tuberculosis (TB) disease or high risk of acquiring TB infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519791

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

  Show 214 Study Locations
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01519791     History of Changes
Other Study ID Numbers: RA0055A, 2011-001729-25
Study First Received: January 19, 2012
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
France: L’Agence nationale de sécurité du médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Certolizumab Pegol - Cimzia
Methotrexate
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Methotrexate
Immunoglobulin Fab Fragments
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
 Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013