ColitisPhase 4GOAL-ARCNCT02687724
Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis
A Phase 4 study testing Golimumab (GLM) in people with Colitis, run by University College Dublin at 1 site in Ireland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis
- What is being tested?
- Golimumab (GLM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2016to Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Informed consent
- Mayo score (including sigmoidoscopy unless performed in previous 3 months)
- Patient's weight and height and abdominal circumference
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Peter Doran, PhD contact
Rabia Hussain contact
Ireland1 site, 1 recruiting
- Recruiting
St Vincent's University Hospital
Dublin
Glen Doherty, g.doherty@st-vincents.ie
Glen Doherty
About this study
Official 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).
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). The primary objective is to ascertain if dose adjustment of GLM based on GLM drug levels and FCP levels results in higher response and remission rates than standard SmPC dosing.
Read the detailed description
UC is a chronic inflammatory bowel disease (IBD) in which the lining of the large intestine become inflamed. There is no official database which gives accurate figures but it is thought that at least 20,000 people are living with IBD in Ireland. Males and females are affected equally and patients can be diagnosed at any age, including babies and children. The peak age of incidence is between the ages of 15 and 35, with a second (smaller) peak from the 50s to 70s.
GLM is a human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology. It is part of the immunosuppressants pharmacotherapeutic group of TNF-α inhibitors. It is licensed for use in several chronic inflammatory conditions including UC, Psoriatic arthritis, axial spondylitis, rheumatoid arthritis.
The design of GOAL-ARC aims to address the impact of dose escalation of GLM immediately following induction and during the subsequent maintenance phase in response to suboptimal drugs levels or persisting inflammatory burden as represented by raised faecal calprotectin (FCP). FCP has been shown to correlate closely to endoscopic disease activity6.
- Conditions
- Colitis
- Being tested
- Golimumab (GLM)
- Medical subject headings
- Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golimumab (GLM)Drug
GLM is a human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment as per SmPC | Active comparator | Patients will receive standard loading dose of GLM of 200/100 mgs at WKS 0 \& 2. They will then receive 100mgs/ 50mgs depending on their weight as per SmPC. Patients will report their modified partial mayo score and SHS score every 4 weeks (PRO) and provide it to the investigator site via a web based application. Receives: Drug: Golimumab (GLM) |
| Intervention Arm | Experimental | Patients will receive standard loading dose of GLM of 200/100 mgs at WKS 0 \& 2. As with Group 1, Patients will report their modified partial mayo and SHS score every four weeks ( the window for this will be +/- one week) and provide it to the investigator site via a web based application. In addition FCP, GLM DL and ADA shall be measured every four weeks. Receives: Drug: Golimumab (GLM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Continuous Clinical Response (pCCR)
Absence of clinical flare, defined as an increase in modified partial Mayo score of 2 points value with accompanying requirement for treatment intervention
Measured: Wk 14 through to Wk 46
Secondary outcomes (8)
Total Mayo Score
The Total Mayo Score is a combined endoscopic and clinical scale used to assess the severity of UC. It is a composite of sub-scores from four categories, including stool frequency, rectal bleeding, findings at endoscopy and physician global assessment (PGA), with a total score ranging from 0 - 12.
Measured: Week 1, Week 46
Partial Mayo Score
Partial Mayo score consists of three subscores including stool frequency, rectal bleeding and PGA, a total score ranges from 0 - 9.
Measured: Week 14
Modified Partial Mayo Score
A modified partial Mayo score comprises of the two PRO sub-scores, rectal bleeding and stool frequency
Measured: Week 1 to Week 46
Week 14 Clinical Response
A decrease from BL in partial Mayo score by ≥30% or a decrease of 3 points. or A decrease from BL in modified partial Mayo of 2 points or a decrease of ≥30% from baseline.
Measured: Week 14
Clinical Remission
Clinical remission is defined as a Mayo score ≤2 points, with no individual sub-score >1.
Measured: Week 46
Clinical Flare
UC symptom recurrence as a defined by modified partial Mayo score increase of 2 points from week 14 value with accompanying requirement for treatment intervention
Measured: Week 14 to Week 46
Corticosteroid Free Remission
Clinical remission at WK 46 with no concomitant steroids
Measured: Week 46
Mucosal healing
A Mayo endoscopic subscore of 0 or 1
Measured: Week 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glen Doherty, Principal investigator, g.doherty@st-vincents.ie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687724
- Sponsor's protocol ID
- UCDCRC/15/007
- Acronym
- GOAL-ARC
- Status last verified
- Jul 2018
- First submitted
- 16 Feb 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT02687724
- Acronym / sponsor ID
- GOAL-ARC / UCDCRC/15/007
- Conditions
- Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). The primary objective is to ascertain if dose adjustment of GLM based on GLM drug levels and FCP levels results in higher response and remission rates than standard SmPC dosing.
Detailed description
UC is a chronic inflammatory bowel disease (IBD) in which the lining of the large intestine become inflamed. There is no official database which gives accurate figures but it is thought that at least 20,000 people are living with IBD in Ireland. Males and females are affected equally and patients can be diagnosed at any age, including babies and children. The peak age of incidence is between the ages of 15 and 35, with a second (smaller) peak from the 50s to 70s.
GLM is a human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology. It is part of the immunosuppressants pharmacotherapeutic group of TNF-α inhibitors. It is licensed for use in several chronic inflammatory conditions including UC, Psoriatic arthritis, axial spondylitis, rheumatoid arthritis.
The design of GOAL-ARC aims to address the impact of dose escalation of GLM immediately following induction and during the subsequent maintenance phase in response to suboptimal drugs levels or persisting inflammatory burden as represented by raised faecal calprotectin (FCP). FCP has been shown to correlate closely to endoscopic disease activity6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment as per SmPC | Active comparator | Drug: Golimumab (GLM)Patients will receive standard loading dose of GLM of 200/100 mgs at WKS 0 \& 2. They will then receive 100mgs/ 50mgs depending on their weight as per SmPC. Patients will report their modified partial mayo score and SHS score every 4 weeks (PRO) and provide it to the investigator site via a web based application. |
| Intervention Arm | Experimental | Drug: Golimumab (GLM)Patients will receive standard loading dose of GLM of 200/100 mgs at WKS 0 \& 2. As with Group 1, Patients will report their modified partial mayo and SHS score every four weeks ( the window for this will be +/- one week) and provide it to the investigator site via a web based application. In addition FCP, GLM DL and ADA shall be measured every four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golimumab (GLM)GLM is a human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology | Drug | Intervention Arm, Standard treatment as per SmPC |
Primary outcome
Patient Continuous Clinical Response (pCCR)
Time frame: Wk 14 through to Wk 46
Absence of clinical flare, defined as an increase in modified partial Mayo score of 2 points value with accompanying requirement for treatment intervention
8 secondary outcomes
Total Mayo Score
Time frame: Week 1, Week 46
Partial Mayo Score
Time frame: Week 14
Modified Partial Mayo Score
Time frame: Week 1 to Week 46
Week 14 Clinical Response
Time frame: Week 14
Clinical Remission
Time frame: Week 46
Clinical Flare
Time frame: Week 14 to Week 46
Corticosteroid Free Remission
Time frame: Week 46
Mucosal healing
Time frame: Week 46
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Doran, PhD contact
Rabia Hussain contact
Glen Doherty principal investigator
g.doherty@st-vincents.ie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Golimumab (GLM) in people with Colitis, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Doran, PhD (peter.doran@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Continuous Clinical Response (pCCR) (time frame: Wk 14 through to Wk 46). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.