A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01715896
First received: October 16, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Mavrilimumab or golimumab alternating with placebo subcutaneous injection
Phase 2

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 Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Proportion of subjects who achieve American College of Rheumatology 20%/50%/70% improvement [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

    Also included in the primary outcome measure are:

    disease activity score in 28 joints (DAS28) < 2.6, and Health Assessment Questionnaire Disability Index (HAQ-DI) improvement > 0.25



Secondary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: Informed consent through to Week 24 ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Maximum Serum Concentrations Following Mavrilimumab [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: No ]
    Maximum serum concentrations (Cmax) following mavrilimumab administration

  • Incidence of Anti-drug Antibodies Against Mavrilimumab [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: Yes ]
    Number of participants with anti-drug antibodies against mavrilimumab

  • DAS28-CRP [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: No ]
    Change from baseline DAS28-CRP

  • Individual ACR components [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: No ]
    Swollen and tender joint counts, patient assessment of pain, patient global assessment, physician global assessment, HAQ-DI, CRP and ESR

  • FACIT-fatigue [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: No ]
    Change from baseline in FACIT-fatigue

  • ACRn [ Time Frame: Day 1 to week 24 ] [ Designated as safety issue: No ]
    ACRn

  • DAS28 EULAR response [ Time Frame: Every 2 weeks for 24weeks ] [ Designated as safety issue: No ]
    Including treatment and number of anti-TNF failures

  • DAS28 Low Disease Activity [ Time Frame: Every 2 weeks for 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of Serious Adverse Events [ Time Frame: Informed consent through to Week 24 ] [ Designated as safety issue: Yes ]
    Number of participants with serious adverse events

  • Incidence of Abnormal Laboratory Values [ Time Frame: Informed consent through to Week 24 ] [ Designated as safety issue: Yes ]
    Number of participants with abnormal laboratory values

  • Incidence of Abnormal Vital Sign Values [ Time Frame: Informed consent through to Week 24 ] [ Designated as safety issue: Yes ]
    Number of participants with abnormal vital sign values

  • Incidence of Abnormal Pulmonary Function Test Values [ Time Frame: Informed consent through to Week 24 ] [ Designated as safety issue: Yes ]
    Number of participants with abnormal pulmonary function test values


Enrollment: 215
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mavrilimumab
GM-CSFR alpha inhibitor Q2W + MTX
Biological: Mavrilimumab or golimumab alternating with placebo subcutaneous injection
GM-CSR alpha inhibitor or TNF alpha Inhibitor alternating with placebo
Other Name: Active control
Active Comparator: Golimumab alternating with placebo
TNF alpha Inhibitor alternating with placebo Q2W + MTX
Biological: Mavrilimumab or golimumab alternating with placebo subcutaneous injection
GM-CSR alpha inhibitor or TNF alpha Inhibitor alternating with placebo
Other Name: Active control

Detailed Description:

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the current study is to compare the efficacy and safety of a subcutaneous dose of mavrilimumab with a marketed treatment for RA (golimumab) in 120 adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two anti-TNF agents with mavrilimumab

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of at least moderately-active adult onset RA
  • At least 4 swollen joints
  • Inadequate response to one or two anti-TNF agents other than the study comparator, as defined by the protocol
  • Receiving oral or injectable methotrexate, as defined by the protocol.

Exclusion Criteria:

  • A rheumatic autoimmune disease or other inflammatory joint disease other than RA
  • Previous treatment with biologic therapies other than anti-TNF for RA.
  • Treatment with other DMARDs or NSAIDs, as defined by the protocol.
  • Medical history as defined by the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715896

  Show 39 Study Locations
Sponsors and Collaborators
MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01715896     History of Changes
Other Study ID Numbers: CD-IA-CAM-3001-1107
Study First Received: October 16, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration
France: Agence Francaise de Securite Sanitaire des Produits de Sante

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014