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


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Rheumatoid Arthritis

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Trial Information

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


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


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.

Type of Study:

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

Outcome Measure:

Proportion of subjects who achieve American College of Rheumatology 20%/50%/70% improvement

Outcome Description:

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

Outcome Time Frame:

24 Weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CD-IA-CAM-3001-1107

NCT ID:

NCT01715896

Start Date:

March 2013

Completion Date:

October 2015

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid
  • Necrosis

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