A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

This study is currently recruiting participants.
Verified April 2014 by MedImmune LLC
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01712399
First received: October 19, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: mavrilimumab subcutaneous Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Informed consent through to approximately 5 year total ] [ Designated as safety issue: Yes ]
    The occurrence of AEs and SAEs

  • Safety and Tolerability [ Time Frame: Various timepoints from Day 1 through to approximately 5 years ] [ Designated as safety issue: Yes ]
    Vital sign measurements - blood pressure, heart rate, temperature, respiratory rate

  • Safety and Tolerability [ Time Frame: From Day 1 (pre-dose) through to approximately 5 year total ] [ Designated as safety issue: Yes ]
    Clinical lab measurements - chemistry and hematology

  • Safety and Tolerability [ Time Frame: From Day 1 (pre-dose) through to approximately 5 year total ] [ Designated as safety issue: Yes ]
    Pulmonary function tests and dyspnoea score


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mavrilimumab Q2W + MTX
GM-CSFR alpha inhibitor
Biological: mavrilimumab subcutaneous Injection
GM-CSFR alpha inhibitor

Detailed Description:

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), 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. This study is an open-label extension study for subjects who have participated in one of the qualifying development program studies with mavrilimumab. Participation in this study will allow these subjects to continue to receive long-term treatment with mavrilimumab. The data from this study will provide an evaluation of the long-term safety of mavrilimumab in adult subjects with RA. In addition, long-term exploratory efficacy outcomes such as joint damage and disability will be evaluated.

  Eligibility

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

Inclusion Criteria:

  • Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization.
  • No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist

Exclusion Criteria:

  • Subjects who have been permanently discontinued from investigational product in previous qualifying study.
  • Any new conditions or worsening of any pre-existing conditions as defined in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712399

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

  Show 52 Study Locations
Sponsors and Collaborators
MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01712399     History of Changes
Other Study ID Numbers: CD-IA-CAM-3001-1109
Study First Received: October 19, 2012
Last Updated: April 16, 2014
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 April 22, 2014