Selasa, 04 Mei 2010

Penelitian Sub Bagian Reumatologi

  • LJP 394 - 90 - 14, A Randomized, Double-Blind, Placebo Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with A History of Renal Disease.
  • Principal Investigator: dr. Rachmat Gunadi W., SpPD-KR
  • Sub Investigator: dr. Riardi Pramudiyo, SpPD-KR, dr. Sumartini Dewi, SpPD., M.Kes, dr. Laniyati Hamijoyo, SpPD-KR., M.Kes
  • Status: Finished (Feasibility: 26 September 2007, Komite Etik: 4 Desember 2007, Site Initiation: 23 Januari 2008, Berakhir: 13 Perbruari 2009)
  • Sponsor: La Jolla
  • Jumlah Pasien: Screening 8, Randomisasi: 4
  • WA 20500, A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multi-Centre Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab  in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus.
  • Principal Investigator: dr. Rachmat Gunadi W., SpPD-KR
  • Sub Investigator: dr. Riardi Pramudiyo, SpPD-KR, dr. Sumartini Dewi, SpPD., M.Kes, dr. Laniyati Hamijoyo, SpPD-KR., M.Kes
  • Status: Sedang dalam Safety Follow Up (Feasibility: 23 Oktober 2007, Komite Etik: 5 September 2008, Site Initiation: 4 Nopember 2008, Berakhir: 19 Oktober 2009)
  • Sponsor: Roche and Genentech
  • Jumlah Pasien: Screening 4, Randomisasi: 1
  • IL1T - GA - 0815, A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate Lowering Therapy.
  • Principal Investigator: dr. Rachmat Gunadi W., SpPD-KR
  • Sub Investigator: dr. Riardi Pramudiyo, SpPD-KR, dr. Laniyati Hamijoyo, SpPD-KR., M.Kes, dr. Andri Reza Rahmadi, SpPD., M.Kes
  • Status: Ongoing (Feasibility: 20 November 2008, Komite Etik: 22 Mei 2009, Site Initiation: 14-15 September 2009)
  • Sponsor: Regeneron
  • Jumlah Pasien: Screening 8, Randomisasi: 2
  • IL1T - GA - 0816, A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy.
  • Principal Investigator: dr. Rachmat Gunadi W., SpPD-KR
  • Sub Investigator: dr. Riardi Pramudiyo, SpPD-KR, dr. Laniyati Hamijoyo, SpPD-KR., M.Kes, dr. Andri Reza Rahmadi, SpPD., M.Kes
  • Status: Ongoing (Feasibility: 20 November 2008, Komite Etik: 22 Mei 2009, Site Initiation: 14-15 September 2009)
  • Sponsor: Regeneron
  • A Randomized, Double-Blind, Parallel Group, Phase I study to demonstrate equivalence of CT-P13 with Remicade with respect to the Pharmacokinetic profile.
  • Status: Masih tahap persiapan (Feasibility: 2 Februari 2010)
  • Sponsor: Celltrion
  • A Randomized, Double Blind, Parallel Group, Phase III Study to Demostrate Equivalence in Efficacy and Safety of CT-P13 with remicade both administrated in Combination with Methotrexate.
  • Status: Masih tahap persiapan (Feasibility: 2 Februari 2010)
  • Sponsor: Celltrion
  • Multicenter, Double-Blind, Placebo-Controlled Study in which Subjects will be Randomized to Receive Subcutaneously either Atacicept (one of 2 doses) or matching placebo, once weekly for 52 weeks.
  • Status: Masih tahap persiapan (Feasibility: 20 Februari 2010)
  • Sponsor: Merck Serono / EMD Serono
  • 12 Month, Non-interventional, observational study in patients with Chronic Refractory Gout.
  • Status: Masih tahap persiapan (Feasibility: 20 Februari 2010)
  • Sponsor: Pharmaceutical Company 
  • A Phase III, Multicenter, Randomized, Double-Blind, Placebo Controlled, 52-Week Study to Evaluate the Eficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)
  • Status: Masih tahap persiapan (Feasibility: 10 Maret 2010) 
  • Sponsor: Ely Lilly and Company 

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