Center for Innovative Therapy

Biomarker Laboratory

Clinical Trials

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SLE

• Genentech IFN3958g. A Phase I, DBPCRCT to evaluate the an anti-IFNalpha mAb in adults with SLE. Bottom Line: Mild SLE; treatment – anti-interferon mAb

• MedImmune MI-CP152. A Phase IB, DBPCRCT (with open-label extention) to evaluate the  MEDI-545 in SLE. Bottom Line: Mild SLE; treatment – anti-interferon mAb

• Genentech WA20499 (BEGIN); A DBPCRCT to evaluate Ocrelizumab in Patients with moderate to severe SLE. Bottom Line: SLE, moderate to severe (other than nephritis): treatment – a new anti-CD20 mAb

Rheumatoid Arthritis

• Genentech WA20495/ACT3986g (SCRIPT); A DBPCRCT to evaluate Ocrelizumab in Patients with Active RAs who had Inadequate response to Anti-TNF-α-Therapy. Bottom Line: RA failed TNF inhibitor; treatment – a new anti-CD20 mAb

• Biogen Idec 104RA203. A Phase 2b, DBPCRCT (+ long term open extension) of BG9924 plus MTX in patients with Active Rheumatoid Arthritis who have had an Inadequate response to Anti-TNF Therapy. Bottom Line: RA failed TNF inhibitor; treatment – a TNF-beta inhibitor

• Abbott M06-810 (OPTIMA). DBPCRCT (+ long term open extension) of MTX vs MTX+adalimumab in Early RA; treatment guided by disease activity/response. Bottom Line: Early RA, Rx naive; treatment – MTX vs MTX+TNF-I

• UCB. DBPCRCT (+ long term open extension) of MTX vs MTX+certolizumab pegol in RA; past TNF use  OK Bottom Line: RA on MTX; treatment – new TNF-Inhibitor

• Genentech  (Sundial); open label study of rituximab in RA in combination with various DMARDs. Bottom Line: Active RA, various DMARDs: treatment – anti-CD20 mAb

• Roche, ROSE Study; DBPCRCT (+ long term open extension) of tocilizumab (anti-IL-6R mAb) in patients with active  RA on MTX. Bottom Line: New biologic (anti-IL-6R mAb) in active RA. May have been exposed to TNF-I in past.Psoriatic Arthritis (PsA). 

• Rituximab in PsA. Bottom LineOpen label study of Rituximab in PsA.

Crohn’s Disease

• COSPAR C87065; DBPCRCT (+ long term open label extension) of certolizumab pegol in Crohn’s Disease.

Other Diseases

• Psoriatic Arthritis (PsA).  Rituximab PsA. Open label study of rituximab in patients who have active PsA. Can be on DMARDs, can be TNF failure. Bottom Line: Open label study of Rituximab in PsA.