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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02687724
• Date of registration: 16/02/2016
• Prospective Registration: Yes
• Primary sponsor: University College Dublin
• Public title: Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis GOAL-ARC
• Scientific title: GLM 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).
• Date of first enrolment: June 2016
• Target sample size: 136
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02687724
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Ireland

Contacts

• Name: Peter Doran, PhD

• Name: Glen Doherty

• Name: Glen Doherty
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colitis

Intervention(s)

Drug: Golimumab (GLM)

Primary Outcome(s)

Patient Continuous Clinical Response (pCCR) [Time Frame: Wk 14 through to Wk 46]

Secondary Outcome(s)

Week 14 Clinical Response [Time Frame: Week 14]

Clinical Flare [Time Frame: Week 14 to Week 46]

Mucosal healing [Time Frame: Week 46]

Corticosteroid Free Remission [Time Frame: Week 46]

Clinical Remission [Time Frame: Week 46]

Modified Partial Mayo Score [Time Frame: Week 1 to Week 46]

Partial Mayo Score [Time Frame: Week 14]

Total Mayo Score [Time Frame: Week 1, Week 46]

Secondary ID(s)

UCDCRC/15/007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors