SCHOOL OF MEDICINE

Department of Medicine

Rheumatology

Research

Jana Hilligoss, Project Manager
Clinical Research Center for Pain
and Fibromyalgia Studies
National Institute for Fitness and Sport (NIFS)
250 University Blvd., Suite 118-122
☎ : (317) 274-1755
jhilligo@uupui.edu

If you are interested in participating in the fibromyalgia research please call Janna Hilligoss at 274-1755.


The Division of Rheumatology actively participates in the following research activities:

IRB # 0608-07 Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies, Protocol # WA18696
A 5 year study, MRA infusions monthly in Rheumatoid Arthritis Patients that may also be receiving Methotrexate

Primary Objectives:
To assess the long-term safety of MRA with regard to adverse events and laboratory result abnormalities

To explore the possibility to reduce concomitant steroid treatment

To determine the long-term efficacy of MRA with regard to reduction in signs and symptoms

Secondary Objectives:
To explore the pharmacokinetics, immunogenicity and pharmacodynamic parameters of MRA in this patient population


IRB # 0612-14 A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment

This is a randomized, double-blind study of the safety and efficacy of ocrelizumab in subjects with rheumatoid arthritis (RA). The study will consist of a 48 week double-blind treatment period and a study extension period of at least a further 48 weeks (i.e. at least 96 weeks participation). If at this time the study subject’s peripheral blood B cell count has not returned to their baseline value or into the lower limit of normal (whichever is the lower), visits will continue every 12 weeks until this condition is met.

Patients that are withdrawn from either the double-blind treatment period or the study extension period will enter Safety Follow Up which will end either at the point that 48 weeks have elapsed since the last exposure to blinded study medication/open label ocrelizumab treatment (as applicable) or at the time that their peripheral blood B cell count has returned to their baseline value or into the lower limit of normal (whichever is the lower), as applicable.

Primary Objectives
To determine the efficacy and safety of ocrelizumab versus placebo in reducing signs and symptoms of RA, when used in combination with methotrexate in subjects with active RA who have an inadequate response to methotrexate therapy.

Secondary Objectives
To assess the efficacy of ocrelizumab to slow or inhibit structural damage in these patients (using radiographs).

To assess the effect of ocrelizumab on physical function in this patient population.

To investigate the pharmacokinetics and pharmacodynamics of ocrelizumab.


IRB # 0703-33 A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, INTERNATIONAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OCRELIZUMAB COMPARED TO PLACEBO IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO AT LEAST ONE ANTI-TNF-A THERAPY

This is a randomized, double-blind study of the safety and efficacy of ocrelizumab in subjects with rheumatoid arthritis (RA). The study will consist of a 48 week double-blind treatment period and a study extension period of at least a further 48 weeks (i.e. at least 96 weeks participation). If at this time the study subject’s peripheral blood B cell count has not returned to their baseline value or into the lower limit of normal (whichever is the lower), visits will continue every 12 weeks until this condition is met.

Patients that are withdrawn from either the double-blind treatment period or the study extension period will enter Safety Follow Up which will end either at the point that 48 weeks have elapsed since the last exposure to blinded study medication/open label ocrelizumab treatment (as applicable). If at this time the peripheral blood B cell count is still low, patients should continue visits every 12 weeks until the B cell count has returned to the baseline value or into the lower limit of the normal range (whichever is the lower).

Primary Objectives
To determine the efficacy and safety of ocrelizumab versus placebo in reducing signs and symptoms of RA, when used in combination with methotrexate or leflunomide given either alone or in combination with other non-biologic DMARDs in subjects with active RA who have an inadequate response to at least one anti-TNF- ? therapy.

Secondary Objectives
To assess the efficacy of ocrelizumab to slow or inhibit structural damage in these patients (using radiographs).

To assess the effect of ocrelizumab on physical function in this patient population.

To investigate the pharmacokinetics and pharmacodynamics of ocrelizumab.


IRB # 0705-17 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapy
This is a randomized, double-blind, multi-center study. This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 (SC) versus placebo in subjects with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.

Subjects may participate in this study for up to 26 weeks. Over the treatment period (Visits 1 to 8/Weeks 0 to 12), subjects will be dosed every other week for 12 weeks with an initial loading dose of 120 mg, or placebo at Weeks 0 and 1. Subjects are to return to the clinic for a follow-up visit 2 weeks after the last dose (Visit 9/Week 14). Subjects who continue in the study until follow-up (Visit 9/ Week 14) will be offered the option to enter a safety extension study (under a separate protocol) at that time.

Subjects who do not enroll into the safety extension study will be followed for safety assessments for an additional 12 weeks (until Visit 12/Week 26) under this protocol.

Primary Objectives
To evaluate the efficacy of BG9924 when administered in combination with methotrexate (MTX) to subjects with active RA who have had an inadequate response to anti-TNF therapy

Secondary Objectives
To assess the safety and tolerability of BG9924 in this patient population.
To assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile of BG9924 in this patient population.
To investigate the pharmacokinetics and pharmacodynamics of BG9924.

Markers of Progression of Knee Osteoarthritis
PI – Steven Mazzuca, PhD
Agency: National Institute of Health