Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC)

This is an interventional treatment trial for Colitis Read More

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