Infuse change in patients with moderately to severely active Crohn’s disease (CD) who had an inadequate response to conventional therapy
Treat beyond symptom control with REMICADE®
|REMICADE® clinical trials1-5|
Targan: A registration trial for REMICADE®
Targan study overview6*†
- 12-week, multicenter, randomized, double-blind, placebo-controlled trial (N=108)
- Patients were randomly assigned to receive a single infusion of
- REMICADE® 5 mg/kg‡
- REMICADE® 10 mg/kg§ (not an approved induction dose)
- REMICADE® 20 mg/kg (not an approved dose)
|Featured Targan study endpoints—click each endpoint to learn more|
|Primary endpoint||Secondary endpoints|
Baseline patient characteristics6
- Median disease duration: 12 years (calculated from all patient groups)
- CD (colitis, ileitis, or ileocolitis) ≥6 months' duration
- CDAI ≥220 and ≤400
- Previous CD-related surgery (%)
- Placebo: 52%
- REMICADE® 5 mg/kg: 44%
- REMICADE® 10 mg/kg: 50%
- REMICADE® 20 mg/kg: 50%
- Patients on corticosteroids ≥20 mg/day
- Placebo: 24%
- REMICADE® 5 mg/kg: 26%
- REMICADE® 10 mg/kg: 29%
- REMICADE® 20 mg/kg: 25%
Click here for a complete study design of Targan.
ACCENT I: A Crohn's disease clinical trial evaluating infliximab in a new long-term treatment regimen
ACCENT I study overview2,3II
- 1-year, multicenter, randomized, double-blind trial (N=545)
- All patients received initial infusion of REMICADE® 5 mg/kg at Week 0
- At Week 2, patients were randomized based on clinical response to 1 of 3 maintenance treatment groups through Week 54¶:
- Group I: Placebo at Weeks 2, 6, and then every 8 weeks
- Group II: REMICADE® 5 mg/kg at Weeks 2, 6, and then every 8 weeks
- Group III: REMICADE® 5 mg/kg at Weeks 2 and 6, and then REMICADE® 10 mg/kg every 8 weeks
|Featured ACCENT I study endpoints—click each endpoint to learn more|
|Co-primary endpoints||Secondary endpoints|
Baseline patient characteristics2
- Median disease duration: 7.9 years
- CD ≥3 months' duration
- CDAI ≥220 and ≤400
- Previous CD-related surgery: 51%
- Patients on corticosteroids >20 mg/day: 16%
Click here for a complete study design of ACCENT I.
Serious and sometimes fatal side effects have been reported with REMICADE®. Infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens (e.g., TB, histoplasmosis) have been reported. Lymphoma, including cases of fatal hepatosplenic T-cell lymphoma (HSTCL), and other malignancies have been reported, including in children and young adult patients. Due to the risk of HSTCL, carefully assess the risk/benefit especially if the patient has Crohn's disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment. REMICADE® is contraindicated in patients with severe hypersensitivity reactions to REMICADE® and certain patients with congestive heart failure. Other serious side effects reported include melanoma and Merkel cell carcinoma, hepatitis B reactivation, hepatotoxicity, hematological events, hypersensitivity, neurological events, and lupus-like syndrome. Please see related and other Important Safety Information.
SONIC: The study of biologic- and immunomodulator-naïve patients in Crohn's disease
SONIC study overview4,5#
- Multicenter, randomized, double-blind study (N=508)
- Primary phase: Primary endpoint analysis at Week 26 (N=508)
- Study arm I: Azathioprine (AZA) 2.5 mg/kg/day + placebo infusion (n=170)
- Study arm II: REMICADE® 5 mg/kg + placebo capsules (n=169)
- Study arm III: REMICADE® 5 mg/kg + AZA 2.5 mg/kg/day (n=169)
- Extension phase: Patients who completed first 30 weeks, continuing with initial regimen (N=280)
- Study arm I: AZA 2.5 mg/kg/day + placebo infusion (n=75)
- Study arm II: REMICADE® 5 mg/kg + placebo capsules (n=97)
- Study arm III: REMICADE® 5 mg/kg + AZA 2.5 mg/kg/day (n=108)
|Featured SONIC study endpoints—click each endpoint to learn more|
|Primary endpoints||Secondary endpoints|
Baseline patient characteristics4,5
- Median disease duration: 2.2 to 2.4 years
- CD (colitis, ileitis, or ileocolitis) ≥6 weeks' duration
- Crohn's Disease Activity Index (CDAI) ≥220 and ≤450
- Previous CD-related surgery (%)
- Azathioprine (AZA) + placebo: 31.2%
- REMICADE® + placebo: 27.8%
- REMICADE® + AZA: 26%
- Patients on corticosteroids ≥20 mg/day: 18.1% (92/508)
- Failed conventional therapy with 5-ASAs or budesonide, or required repeated courses of steroids before treatment with an immunomodulator or a biologic
Azathioprine (AZA) is not approved by the Food and Drug Administration (FDA) for the treatment of Crohn's disease and its contribution to the effectiveness of use in combination with REMICADE® has not been established. The use of AZA in combination with REMICADE® should take into account the potential risks associated with combination therapy and monotherapy.
Click here for a complete study design of SONIC.
ACCENT II: A Crohn's disease clinical trial evaluating infliximab in a new long-term treatment regimen in patients with fistulizing Crohn's disease
ACCENT II study overview1,3,7
- Multicenter, randomized, double-blind, international trial evaluating the safety and efficacy of long-term maintenance therapy with REMICADE® (N=282) in patients with fistulizing CD**
- All patients received an initial induction regimen of REMICADE® 5 mg/kg at Weeks 0, 2, and 6
- At Week 14 patients were randomized based on clinical response to receive:
- Maintenance dosing with either REMICADE® 5 mg/kg or placebo every 8 weeks
- Non-responders to the initial 3-dose induction regimen were randomized separately
- At Week 22 responders who lost clinical benefit were eligible to cross over to maintenance treatment with REMICADE® 5 mg/kg, if receiving placebo, or to REMICADE® 10 mg/kg, if receiving REMICADE® 5 mg/kg
- Concomitant CD medications could be maintained at a stable dose
|Featured ACCENT II study endpoints—click each endpoint to learn more|
||Secondary endpoints based on number of draining fistulas:|
Baseline patient characteristics7
- Median disease duration
- Placebo group (responders): 12.3 years
- REMICADE® maintenance group (responders): 10.5 years
- Non-responders: 11.7 years
- CD with single or multiple perianal fistulas and/or enterocutaneous fistulas for ≥3 months
- Patients on corticosteroids ≥20 mg/day: 8%
Click here for a complete study design of ACCENT II.
- Data on file. Janssen Biotech, Inc.
- Hanauer SB, Feagan BG, Lichtenstein GR, et al; and the ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002;359:1541-1549.
- REMICADE® (infliximab) Prescribing Information. Janssen Biotech, Inc.
- Colombel JF, Sandborn WJ, Reinisch W, et al, for the SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010;362:1383-1395.
- Targan SR, Hanauer SB, van Deventer SJH, et al, for the Crohn's Disease cA2 Study Group. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. N Engl J Med. 1997;337:1029-1035.
- Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004;350:876-885.