drugset / Trial / NCT02353780

Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept

NCT02353780

RandomizedParallel-groupSingle-blindBasic science

Summary

An Agency for Healthcare Research and Quality executive summary indicated that better comparative effectiveness trial designs are needed to determine the relative merits of existing versus new and expensive biologic drug therapies for rheumatoid arthritis (RA). There are now 9 biologic therapies approved for treating RA. Four classes of biologics (TNF antagonists, B-cell inhibitors, T-cell co-stimulator blocker, and Interleukin-6 receptor blocker) are approved for use in RA patients with moderate or severe disease activity. Several critical questions have arisen, such as 1) what therapy should be prescribed after failure of methotrexate and/or other oral disease modifying antirheumatic drugs (DMARDs) to adequately control disease activity; 2) what is the level of efficacy of the various biologic therapies when compared in head-to-head trials; and 3) what are the mechanisms associated with failure of methotrexate and/or other oral DMARD therapy and responsiveness to biologic therapies. The MAZERATI study will provide the foundation for answering these questions and determining the mechanisms associated with these biologic therapies.

Timeline

Start
2015-03
Primary completion
2017-12-30
Completion
2018-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abatacept Other / unclassified Subcutaneous
Comparator Adalimumab Monoclonal antibody Subcutaneous
Comparator Certolizumab Pegol Protein / enzyme biologic Subcutaneous
Comparator Etanercept Protein / enzyme biologic Subcutaneous
Comparator Infliximab Monoclonal antibody Subcutaneous
Comparator Tocilizumab Monoclonal antibody Subcutaneous
Comparator humire Unknown Subcutaneous

Indications