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A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

This study is currently recruiting participants.
Verified April 2013 by MedImmune LLC
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01706926
First received: October 3, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to see if mavrilimumab can provide benefit to subjects with rheumatoid arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Mavrilimumab or 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 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Change from baseline in disease activity score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    DAS28(CRP)

  • Proportion of subjects showing an improvement [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    ACR critieria


Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Informed consent through to end of subject participation in the study, approximately 40 weeks ] [ Designated as safety issue: Yes ]
    Incidence of adverse events (AEs) and serious adverse events (SAEs). Laboratory measurements, vital signs, PFTs and dysnoea scores

  • The response rates acheived at each visit [ Time Frame: Biweekly for 24 weeks ] [ Designated as safety issue: No ]
    ACR20, ACR50, ACR70, ACRn, DAS28 Eular response

  • Effect of Mavrilimumab on Pain and Fatigue [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Using patient reported outcomes, patiemt assessment of pain and FACIT-fatigue

  • Pharmacokinetics (PK) [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: Yes ]
    Mavrilimumab serum concentrations

  • Immunogenicity (IM) [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: Yes ]
    Number of subjects with anti-drug antibodies against mavrilimumab

  • Remission and low diease activity rates [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    DAS28


Estimated Enrollment: 280
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose mavrilimumab + MTX
GM-CSFR alpha inhibitor
 Drug: Mavrilimumab or placebo subcutaneous Injection
GM-CSFR alpha inhibitor
Active Comparator: Medium dose mavrilimumab + MTX
GM-CSFR alpha inhibitor
 Drug: Mavrilimumab or placebo subcutaneous Injection
GM-CSFR alpha inhibitor
Active Comparator: High dose mavrilimumab + MTX
GM-CSFR alpha inhibitor
 Drug: Mavrilimumab or placebo subcutaneous Injection
GM-CSFR alpha inhibitor
Placebo Comparator: Placebo Q2W + MTX
Placebo
 Drug: Mavrilimumab or placebo subcutaneous Injection
GM-CSFR alpha inhibitor

Detailed Description:

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still 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 study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (ie, 24 weeks). The results of this study will form the basis for future clinical studies 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 adult onset RA in line with the protocol
  • Moderately active disease in line with the protocol
  • A pre-defined number of swollen joints in line with the protocol
  • Inadequate response to one or more conventional DMARDs
  • No evidence of respiratory disease

Exclusion Criteria:

  • A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement secondary to RA
  • A history of, or current, inflammatory joint disease other than RA
  • Previous treatment with the investigational drug
  • Discontinuation of a biologic DMARD due to lack of efficacy.
  • Non-compliant concurrent medications
  • Non-compliance with medical history criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706926

Contacts
Contact: MedImmune, Medical Advisor clinicaltrialenquiries@medimmune.com
Contact: MedImmune, Senior Clinical Scientist

  Show 59 Study Locations
Sponsors and Collaborators
MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01706926     History of Changes
Other Study ID Numbers: CD-IA-CAM-3001-1071
Study First Received: October 3, 2012
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013