GOAL-ARCGLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC).

Fecha de inicio: 1 de junio de 2016

Inclusion Criteria: * Patients ≥ 18 years of age * Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol * Established diagnosis of UC and moderate-to-severe disease activity, defined as a Mayo score of 6-12, with an endoscopic subscore ≥2. * Patients had an inadequate response to, or had failed to tolerate, 1 or more of the following conventional therapies: oral 5-aminosalicylates, oral corticosteroids, azathioprine (AZA), and/or 6-mercaptopurine (6MP); or corticosteroid dependent (ie, an inability to taper corticosteroids without recurrence of UC symptoms). * Patients concurrently treated with oral 5-aminosalicylates or corticosteroids were to receive a stable dose for at least 2 weeks before baseline, and patients receiving AZA and/or 6MP were to receive a stable dose for at least 4 weeks before baseline. Patients were required to maintain stable doses of their concomitant UC medications during the study. * Female subjects of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 6 months thereafter OR * Surgical sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy OR * Postmenopausal women with postmenopausal defined as permanent cessation \>1 year of previously occurring menses. * Female subjects' serum pregnancy test performed at the screening visit and urine pregnancy test performed at the baseline visit must be negative. * Subjects have following investigations within 1 month prior to enrolment. * Routine bloods including U\&E, FBC, LFTs, inflammatory markers (CRP) and albumin will be measured. * Medical history, concomitant medications * Intradermal reaction to Tuberculin (PPD skin test) or Mycobacterium tuberculosis antigenspecific interferon-gamma release assay (IGRA) * TB screening: chest X-Ray unless performed in the last 6 months * Stool examination for enteric pathogens including Clostridium difficile * Inclusion/exclusion criteria * Informed consent * Mayo score (including sigmoidoscopy unless performed in previous 3 months) * Patient's weight and height and abdominal circumference Exclusion Criteria: * Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study * Patients aged \<18 years of age * Patients who cannot give informed consent, * Pregnant patients or those who are breastfeeding will be deemed ineligible. * Prior treatment with any anti-TNF agent * Contra-indication to use of GLM (Hypersensitivity to the active substance or to any of the excipients; Active tuberculosis (TB), acute or chronic Hepatitis B infection or other severe infections such as sepsis and/or opportunistic infections including HIV infection; Moderate or severe heart failure (NYHA class III/IV) * Have symptoms or signs suggestive of current active or latent TB upon medical history, physical examination and/or chest radiograph, or positive Mycobacterium tuberculosis antigen-specific interferon-gamma release assay (IGRA) * Patients with a history of, or at imminent risk for, colectomy; who required gastrointestinal surgery within 2 months before screening; * History of colonic mucosal dysplasia or adenomatous colonic polyps that were not removed * Screening stool study positive for enteric pathogens or Clostridium difficile toxin. * Oral corticosteroids at a dose \>40 mg prednisone or its equivalent per day; receipt of cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks before the first study agent injection; or use of an investigational agent within 5 half-lives of that agent before the first study agent injection. * Patients in recent receipt of live vaccinations within 4 weeks prior to enrolment