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Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA) (MARVELOUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01235598
First received: November 4, 2010
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

Phase IIIb study to determine early response to certolizumab pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.


Condition Intervention Phase
Rheumatoid Arthritis
 Other: Placebo, then certolizumab pegol (CZP)
Biological: Certolizumab pegol (CZP)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 16-week Double-blind, Placebo-controlled (for Initial 2 Weeks) Randomized Period, Followed by a 24-week Open-label Extension to Assess Magnetic Resonance Image (MRI) - Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Change in Synovitis measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) score at Week 16 compared to Baseline for Certolizumab Pegol arm [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Change in Synovitis measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) score at Week 8 compared to Baseline for Certolizumab Pegol arm [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change in Synovitis measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) score at Week 4 compared to Baseline for Certolizumab Pegol arm [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Change in Synovitis measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) score at Week 2 compared to Baseline for Certolizumab Pegol arm [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
  • Change in Synovitis measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) score at Week 1 compared to Baseline for Certolizumab Pegol arm [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline to Week 16 in the dynamic Magnetic Resonance Image (MRI) parameter, initiation rate of enhancement (IRE) [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
    Change from Baseline to Week 16 in the dynamic Magnetic Resonance Image (MRI) parameter, initiation rate of enhancement (IRE)

  • Change from Baseline to Week 16 in the dynamic Magnetic Resonance Image (MRI) parameter, maximal enhancement (ME) [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 16 in the dynamic Magnetic Resonance Image (MRI) parameter, Number of voxels (Nvox) with Plateau and Washout pattern [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving a good European League Against Rheumatism (EULAR) response at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of subjects meeting the American College of Rheumatology 20 % criteria (ACR20) at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of subjects meeting the American College of Rheumatology 50 % criteria (ACR50) at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of subjects meeting the American College of Rheumatology 70 % criteria (ACR70) at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 16 in the Disease Activity Index-28 (DAS28 (CRP)) response [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving Disease Activity Index-28 (DAS28 (CRP)) remission status (DAS28 (CRP) < 2.6) at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 16 in bone mineral density as measured by Digital XRay (DXR) [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 16 in Tender Joint Count (TJC) [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change Baseline to Week 16 in Swollen Joint Count (SJC) [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 16 in Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) ratio from Baseline to Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Correlation of change in Synovitis from Baseline as measured by Magnetic Resonance Image (MRI) with European League Against Rheumatism (EULAR) response at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Correlation of change in Synovitis from Baseline as measured by Magnetic Resonance Image (MRI) with American College of Rheumatology 20 % criteria (ACR20) at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Correlation of change in Synovitis from Baseline as measured by Magnetic Resonance Image (MRI) with American College of Rheumatology 50 % criteria (ACR50) at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Correlation of change in Synovitis from Baseline as measured by Magnetic Resonance Image (MRI) with American College of Rheumatology 70 % criteria (ACR70) at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Correlation of change in Synovitis from Baseline as measured by Magnetic Resonance Image (MRI) with Disease Activity Index-28 (DAS28 (CRP)) response at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Correlation of change in Synovitis from Baseline as measured by Magnetic Resonance Image (MRI) with changes in hand bone mineral density as measured by Digital XRay (DXR) at Week 16 [ Time Frame: From Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis score at Week 1 Placebo (PBO) versus Certolizumab Pegol (CZP) [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis score at Week 2 Placebo (PBO) versus Certolizumab Pegol (CZP) [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: December 2010
Estimated Study Completion Date: May 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo followed by certolizumab pegol (CZP)
Placebo, saline solution for sc injection at Week 0 followed by certolizumab pegol (CZP) 400 mg at Weeks 2, 4, and 6, then certolizumab pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
 Other: Placebo, then certolizumab pegol (CZP)
Placebo provided for the first subcutaneous injection in single-use vials at Week 0 (2 vials required), then certolizumab pegol (CZP) 400 mg at Weeks 2, 4 and 6, followed by certolizumab pegol (CZP) 200 mg every 2 weeks from Week 8 to Week 40
Other Names:
  • Cimzia®
  • CZP
  • CDP870
Experimental: Certolizumab pegol (CZP)
Certolizumab pegol (CZP) for sc injection (400 mg at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40)
 Biological: Certolizumab pegol (CZP)
Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4, followed by certolizumab pegol (CZP) 200 mg every 2 weeks from Week 6 until Week 40
Other Names:
  • Cimzia®
  • CZP
  • CDP870

Detailed Description:

To identify the efficacy of certolizumab pegol (CZP) on synovitis in dynamic MRI parameters; to make the correlation between European League Against Rheumatism (EULAR), American College of Rheumatology (ACR)p, Disease Activity Score-28 (DAS 28) responses, and Digital XRay (DXR) assessment with reduction of synovitis.

  Eligibility

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

Inclusion Criteria:

  • Subjects with a diagnosis of adult-onset rheumatoid arthritis (RA) of at least 3 months duration but no longer than 15 years
  • Subjects with an active adult rheumatoid arthritis disease
  • Subjects who have been on disease-modifying anti-rheumatic drug (DMARD) therapy for at least 12 weeks

Exclusion Criteria:

  • Subject must not have a secondary, non-inflammatory type of musculoskeletal condition (eg, osteoarthritis or fibromyalgia) that in the investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of rheumatoid arthritis (RA)
  • Subject must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis)
  • Subject must not have a history of an infected joint prosthesis at any time with prosthesis still in situ
  • Subject must not have received more than 1 biological agent
  • Subject must not have a history of lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
  • Subject with known tuberculosis (TB) disease, high risk of acquiring TB infection or latent TB infection
  • Subject must not have a known hypersensitivity to any components of the investigational medicinal product
  • Subject must not have contraindications for magnetic resonance image (MRI) and contrast agent
  • Subject must not have any other condition which, in the investigator's judgement, would make them unsuitable for inclusion in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235598

Locations
Denmark
003
Frederiksberg, Denmark
002
Hellerup, Denmark
001
Hvidovre, Denmark
016
Slagelse, Denmark
Netherlands
012
Nijmegen, Netherlands
010
Utrecht, Netherlands
Poland
019
Warszawa, Poland
018
Warszawa, Poland
Sweden
008
Goteburg, Sweden
004
Malmoe, Sweden
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: NCT01235598     History of Changes
Other Study ID Numbers: RA0028, 2009-013758-33
Study First Received: November 4, 2010
Last Updated: April 30, 2013
Health Authority: Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by UCB, Inc.:
Cimzia®
CDP870
CZP
 Certolizumab Pegol
Rheumatoid Arthritis
MRI

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 22, 2013