Currently Enrolling Studies July 2006
(Please see end of list for contact information)
Studies in Systemic Lupus Erythematosus (SLE)
Title: Aspreva Lupus Management Study (ALMS, almstudy.com)
Sponsor: Aspreva Pharmaceuticals and F. Hoffmann-La Roche
Disease: Lupus nephritis (WHO class III, IV, or V)
Synopsis: Two phase study, 6 month induction phase followed by up to 36 month maintenance phase. In the induction phase, subjects are randomized 1:1 to receive either cyclophosphamide (Cytoxan) or CellCept. After the induction phase, subjects who have had a response to the therapy are re-randomized (1:1) to receive either CellCept or azathioprine (Imuran).
Contact: Jann Wagner
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab I subjects with Moderate to Severe Systemic Lupus Erythematosus. (EXPLORER)
Sponsor: Genentech, Inc.
Disease: Moderate to severe lupus. Renal (nephritis) or CNS involvement are not allowed.
Synopsis: Subjects who develop a flare of their lupus while on therapy with azathioprine (Imuran), 6-mercaptopurine (6-MP), mycophenolate mofetil (MMF, CellCept), or methotrexate (MTX) are randomized 2:1 to receive rituximab (Rituxan) plus corticosteroids or placebo plus corticosteroids.
Contact: Jann Wagner
Studies in Rheumatoid Arthritis
Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety and Reduction of Signs and Symptoms During Treatment with MRA versus Placebo, in Combination with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Previous Anti-TNF Therapy.
Sponsor: F. Hoffmann-La Roche
Disease: Rheumatoid arthritis
Synopsis: Subjects with active rheumatoid arthritis who are on methotrexate will be randomized 1:1:1 to one of three treatment arms. Two arms will receive MRA (anti-IL6R) at low or high dose, and the third arm will receive placebo. Subjects must have failed therapy with a medication that inhibits TNF [etanercept (Enbrel), infliximab (Remicade), or adalimumab (Humira)], either because the TNF inhibitor was ineffective or could not be tolerated.
Contact: Ruth Grosskreuz
Title: A Double-Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis.
Sponsor: NIH and the Autoimmunity Centers of Excellence (ACE)
Disease: Rheumatoid arthritis
Synopsis: Subjects with mildly active rheumatoid arthritis will be randomized 1:1 to receiver either Lovastatin or placebo for 12 weeks. Subjects may be on any other medication for their arthritis except infliximab (Remicade). Subjects may not be on a HMG-CoA reducatase inhibitor (statin) at the start of the study, although previous use is allowed.
Contact: Jann Wagner
Studies in Psoriatic Arthritis
Title: Treatment of Psoriatic Arthritis with hOKT3γ1 (Ala-Ala). (partstudy.org)
Sponsor: NIH and the Immune Tolerance Network (ITN)
Disease: Psoriatic arthritis.
Synopsis: Subjects with active psoriatic arthritis while on methotrexate or azathioprine (Imuran) will be randomized 2:1 to receive hOKT3γ1 (Ala-Ala) or placebo. Subjects may have failed previous treatment with a TNF inhibitor [etanercept (Enbrel), infliximab (Remicade), or adalimumab (Humira)].
Contact: Ruth Grosskreuz
Future Studies
Title: An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid Arthritis. (SERENE, rastudy.com)
Sponsor: NIH and the Autoimmunity Centers of Excellence (ACE)
Disease: Recent onset (less than 1 year) rheumatoid arthritis
Synopsis: Subjects with active rheumatoid arthritis and less than one year of symptoms will receive standard of care therapy with methotrexate. All subjects will also receive treatment with rituximab. Subjects may not have taken methotrexate prior to starting the study.
Title: A Randomized, Placebo Controlled, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination with Methotrexate, compared to Methotrexate Monotherapy, in Patients with Active Rheumatoid Arthritis.
Sponsor: Roche Products Ltd. and Genentech, Inc.
Disease: Rheumatoid arthritis
Synopsis: Subjects with active rheumatoid arthritis despite therapy with methotrexate will be randomized to one of three treatment arms. Two arms will receive rituximab (at either high or low dose), and the third arm will receive placebo. Subjects may not have previously received rituximab or a TNF inhibitor [etanercept (Enbrel), infliximab (Remicade), or adalimumab (Humira)].
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Multi-Center Study for Treatment of Lupus Nephritis by Inhibition of Tumor Necrosis Factor–α Using Etanercept.
Sponsor: NIH and the Autoimmunity Centers of Excellence (ACE)
Disease: Lupus nephritis (WHO class III or IV, new onset or reactivation of previously treated nephritis)
Synopsis: Subjects will be randomized 1:1 to receive either etanercept (Enbrel) or placebo for 6 months. Subjects must be on corticosteroids and either mycophenolate mofetil (MMF, CellCept) or azathioprine (Imuran) at the time of starting the study. Subjects must not have received treatment with cyclophosphamide (Cytoxan) in the past.
Contacts
Christopher C. Striebich, M.D., Ph.D.
Director, Division of Rheumatology Clinical Research Unit
University of Colorado Denver
1635 N. Ursula St.
Aurora, CO 80045
720-848-1940
Jann Wagner, R.N.
Study Coordinator
720-848-1958
Ruth Grosskreuz, M.D.
Study Coordinator
720-848-1949