Efficacy of Golimumab in Maintaining Deep Remission in UC Patients in Prolonged Remission With Infliximab
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      This study monitors the efficacy and safety of Golimumab in maintaining deep remission and
      quality of life in Ulcerative Colitis patients in deep prolonged remission with Infliximab.
      Patients will be followed up for one year and they will be assessed with biochemical tests
      (C-Reactive Protein , Full Blood Count , Faecal Calprotectin),endoscopic evaluation (MAYO
      Score) and finally histologically.
    

Detailed description: 
      Ulcerative colitis (UC) is a chronic idiopathic relapsing-remitting or continuously active
      inflammatory bowel disease (IBD) which almost exclusively affects the colonic mucosa. Acute
      severe flares of UC may lead onto potential lethal complications, such as massive
      haemorrhage, toxic megacolon, peritonitis, and colectomy whereas chronic active disease may
      lead to functional failure of the large bowel, dysplasia and colorectal cancer. Traditional
      therapeutic targets, such as normalization of stools and absence of rectal bleeding, are no
      longer considered sufficient to prevent the aforementioned long term sequelae of uncontrolled
      colonic inflammation. Thus, new therapeutic targets are emerging which aim at achieving
      optimal long-term outcomes of UC. Along this line, therapy is moving from mere control of
      symptoms towards a more global control of inflammation by achieving and maintaining long-term
      complete clinical remission (relief of abdominal pain, normalization of stools, and cessation
      of rectal bleeding), normalization of serologic (white blood cells and C-Reacting Protein)
      and faecal markers of inflammation (calprotectin), and endoscopic (normal looking mucosa) and
      histologic remission (absence of acute and chronic inflammation on biopsies from the affected
      colonic areas). This composite definition of remission (namely 'complete' or 'deep'
      remission) consisting of appropriate patient reported outcomes (PROs) and objective markers
      of intestinal inflammation may be associated with improved long-term outcomes of disease,
      such prevention of complications, hospitalizations, and colectomy, avoidance of disability
      and maintenance of at least near-normal patient quality of life. This composite clinical and
      biological remission along with mucosal healing and histologic remission is now considered as
      a realistic therapeutic goal.

      Patients fulfilling the inclusion criteria and willing to participate will receive golimumab
      therapy subcutaneously for 1 year.

      Patients will be followed in the outpatient IBD Clinic at 3-month intervals as is the usual
      practice in our department. At each visit patients will undergo clinical evaluation using the
      Partial Mayo score, physical examination, monitor of body weight and body mass index, and
      routine laboratory tests which are included in routine clinical practice of treatment with
      biologic agents in IBD (FBC, Estimated Sedimentation Rate, CRP, Liver Function Tests, Urea,
      Creatinine, serum glucose and electrolytes, and faecal calprotectin) in order to ensure
      effectiveness and safety of treatment. In each visit, patients will fill questionnaires to
      assess quality of life, disability, work productivity, and satisfaction with therapy. The
      daily bowel frequency, rectal bleeding, presence and grading of abdominal pain and the
      overall subjective condition of patient's general health between visits will be recorded
      daily in pre-administered diaries.

      After 1 year of golimumab administration patients will be re-evaluated by endoscopy and
      biopsies in order to define the percentage of patients that remain at deep remission.

      For those patients presenting with a flare of disease during the 1 year follow up, treatment
      will be individualized depending on the severity of the flare.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ulcerative colitis patients in deep remission after 2 years of infliximab administration
      
Keywords: Ulcerative Colitis; Golimumab; Deep and prolonged remission