Tufts Medical Center - Clinical Trials

Rituximab Trial for Patients with Moderate to Severe Lupus (excluding active kidney disease)

· For patients with lupus who are experiencing a disease flare. (There are set criteria by which active disease is defined for this study and the study investigators will help to determine if a patient qualifies.)

· Patients with certain types of active lupus kidney diseases may not be eligible.

· Must be on one of the following medications: Cellcept, Imuran, methotrexate, or 6-MP.

· Qualified participants will be randomized in a ratio of 2:1 to receive either rituximab or placebo by IV infusion (i.e. an individual patient has a 66 percent chance of receiving rituximab in this study).

· The duration of the trial is 1 year for each participant, with a follow up period.

This trial is enrolling participants through January 2007.

Principal Investigator: Elena Massarotti, MD

Study coordinator: Preeti Varma, MD

For more information, contact Dr. Massarotti at 617-636-5792

Rituximab Trial for Patients with Class III/IV Lupus Nephritis

· For patients with biopsy proven class III/IV lupus nephritis (biopsy must be done within twelve months of study entry).

· Eligible patients will be randomized to receive Cellcept with Rituximab or Cellcept with Placebo at a ratio of 1:1.

· The duration of the trial is 1 year for each participant, with a follow up period.

This trial is enrolling participants through July 2007.

Principal Investigator: Elena Massarotti, MD

Study coordinator: Preeti Varma, MD

For more information, contact Dr. Massarotti at 617-636-5792

Open-Label Trials of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects with Systemic Lupus Erythematosus (SLE)

· This study is open only to participants who completed a previous trial with LymphoStat-B.

· This clinical trial is projected to continue for a minimum of 4 years.

· Tufts Medical Center will accept transfer participants in this study.

Principal Investigator: Timothy McAlindon, MD, MPH

Study coordinator: Melynn Nuite, RN, CCRC

For more information, call 617-636-8461.

Studies for Osteoarthritis

Vitamin D for Knee Osteoarthritis

· The aim of this NIH-funded study is to determine if Vitamin D taken once a day by mouth helps to slow the progression of knee OA.

· This is a double-blind, placebo-controlled study in which participants will have a 50 percent chance of receiving vitamin D.

· Participants over the age of 49 can be screened for this study.

· A part of their evaluation during the study, participants will have X-rays, bone density scans and MRIs performed.

· The duration of this study for each participant is 26 months.

· The total number of participants will be 144.

Recruitment is ongoing.

Principal Investigator: Timothy McAlindon, MD, MPH

Study coordinators: Melynn Nuite, RN, CCRC; Laura Wheeler, MPH

For more information call 617-636-5727.

Tai Chi, Strength Training and Education for Knee OA

· This study, funded by the National Center for Complementary and Alternative Medicine, will evaluate the physical and psychological effect of Tai Chi and stretch training and education on Knee OA.

· Participants over age 55 are eligible.

· Twenty-four training classes will be offered in Spring 2007.

· Compensation of up to $200 is available.

Principal Investigator: Chenchen Wang, MD, MSc

For more information call 617-636-3251.

Studies for Rheumatoid Arthritis

Myeloma Receptor Antibody (MRA) Trial for Rheumatoid Arthritis

· For RA patients whose disease is active despite taking methotrexate.

· Patients who are on or who have been treated with etanercept, infliximab, or adalimumab are not eligible.

· This is a double-blind, placebo controlled study in which participants will have a 50 percent chance of receiving MRA by IV infusion.

This study is closed to enrollment.

Principal Investigator: Timothy McAlindon, MD, MPH

Study coordinator: Melynn Nuite, RN, CCRC

For more information call 617-636-8461.

Rituximab Retreatment Trial for Patients with Rheumatoid Arthritis who have failed treatment with TNF inhibitors (etanercept, infliximab, adalimumab)

· All eligible participants will receive rituximab up front.

· Patients with signs of active disease after 6 to 8 months will be eligible for randomization to retreatment with rituximab or traditional therapy.

· The duration of the trial is about one and half years (78 weeks) for each participant.

This study is currently enrolling.

Principal Investigator: Elena Massarotti, MD

Study coordinator: Preeti Varma, MD

For more information, contact Dr. Massarotti at 617-636-5792.

Rituximab Trial for Patients with Rheumatoid Arthritis who are Methotrexate Naïve

· Patients with symptoms of active RA who have not been previously treated with methotrexate.

· Eligible patients will be randomized to receive methotrexate with rituximab at two different doses or methotrexate with placebo.

· The duration of the trial is about three years per patient, or until rituximab is commercially available (rituximab is approved for patients with RA who have failed treatment with TNF inhibitors.

This study is currently enrolling.

Principal Investigator: Elena Massarotti, MD

Study coordinator: Preeti Varma, M.D.

For more information, contact Dr. Massarotti at 617-636-5792.