Golimumab dose variation to achieve response in Colitis

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-004724-62-IE
• Lead Sponsor: CD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-05
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 136

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)
Or
?Patients that are secondary non-responders to anti-TNF agents (lost response after induction therapy) or failed to tolerate a prior anti-TNF agent
?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.
?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 or urine pregnancy test performed at the screening visit must be negative.
?Subjects have following investigations within 1 month prior to enrolment (during screening):
-Routine bloods including U&E, FBC, LFTs, inflammatory markers (CRP) and albumin will be measured.
-Medical history, concomitant medications
-Negative TB screening per local standard of care (unless performed and documented negative in the 6 months prior to enrolment)
-Stool examination for enteric pathogens including Clostridium difficile
-Inclusion/exclusion criteria
-Informed consent
-Mayo score (including sigmoidoscopy unless performed in previous12 weeks, +/- 4 weeks)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 123
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

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.
?Patients who are considered primary non-responders to anti-TNF agents
?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 equal to or greater than 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified