CURRENT RHEUMATOLOGY RESEARCH UNIT TRIALS

RHEUMATOID ARTHRITIS

Rituximab + Methotrexate (MTX)

• MTX naïve patients with early RA (diagnosed within last 4 years)
• 2 doses Rituximab versus placebo

Rituximab + Methotrexate (MTX)

• Patients with an inadequate response to MTX
• All patients given IV Rituximab (no placebo arm)
• Prior treatment with one anti-TNF agent allowed

HuMax (anti-CD20)

• Failed at least one DMARD (does not have to be MTX)
• Current DMARD therapy not necessary
• Prior biologic treatment allowed
• 3 doses IV HuMax versus placebo

SMP-114 (Leflunomide-like compound)

• For patients failing MTX and needing oral combination therapy
• Double-blind placebo-controlled first 6 months
• Open-label active treatment next 6 months
• Excluded if failed > 2 DMARDs (including biologics)

CombinatoRx (Paroxetine)

• Comparing the effect of Paroxetine plus DMARD therapy to that of steroid plus DMARD.
• Must be on a DMARD (any) for at least 3 months
• Prior biologics allowed
• Current steroid use not allowed

AMG-108 (subcutaneous IL-1R blocker) (starts July 2006)

• For biologic naïve patients on stable MTX
• 3 doses AMG-108 versus placebo
• Monthly s/c dosing for 4 months (to week 12, then follow up to week 24)

ANKYLOSING SPONDYLITIS

Adalimumab (anti-TNFa)

• Open-label treatment for all AS patients (including anti-TNF failures)
• Must have failed > 2 NSAIDs

Etanercept vs. Sulfasalazine (SSZ) (starts June 2006)

• To compare efficacy of Etanercept and SSZ (2:1 allocation)
• Must have failed at least 1 NSAID

Golimumab (anti-TNFa) 5 years (starts Aug 2006)

• Placebo-controlled for first 20 weeks (rescue at week 16 if no improvement)
• Active treatment from weeks 20-100, then LTE available for up to 5 years.
• Must have failed at least 1 NSAID

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