Trial Outcomes & Findings for Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels (NCT NCT03124121)

Results Overview

Evaluated using an enzyme-linked immunosorbent assay (ELISA)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

112 participants

Primary outcome timeframe

Week 6 during induction therapy and at the point of study entry during maintenance

Results posted on

2021-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Golimumab Induction Therapy Patients commencing golimumab	Golimumab Maintenance Therapy Patients receiving golimumab maintenance therapy
Overall Study STARTED	42	70
Overall Study COMPLETED	39	67
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Golimumab Induction Therapy n=39 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=67 Participants Patients receiving golimumab maintenance therapy	Total n=106 Participants Total of all reporting groups
Age, Continuous	37 years n=39 Participants	36 years n=67 Participants	36 years n=106 Participants
Sex: Female, Male Female	17 Participants n=39 Participants	30 Participants n=67 Participants	47 Participants n=106 Participants
Sex: Female, Male Male	22 Participants n=39 Participants	37 Participants n=67 Participants	59 Participants n=106 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Week 6 during induction therapy and at the point of study entry during maintenance

Evaluated using an enzyme-linked immunosorbent assay (ELISA)

Outcome measures

Outcome measures
Measure	Golimumab Induction Therapy n=39 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=67 Participants Patients receiving golimumab maintenance therapy
Serum Golimumab Concentration (μg/ml)	3.3 ug/ml Interval 1.3 to 8.0	2.4 ug/ml Interval 0.6 to 7.4

SECONDARY outcome

Timeframe: Week 14 during induction therapy and at the point of study entry during maintenance therapy

Evaluated using the Simple Clinical Colitis Activity Index (SCCAI). Remission defined as SCCAI \< 3.

Outcome measures

Outcome measures
Measure	Golimumab Induction Therapy n=42 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=67 Participants Patients receiving golimumab maintenance therapy
Number of Patients in Clinical Remission	22 Participants	41 Participants

SECONDARY outcome

Timeframe: Week 14 during induction therapy and at the point of study entry during maintenance

Faecal inflammatory marker with higher values suggestive of increasing biochemical disease activity

Outcome measures

Outcome measures
Measure	Golimumab Induction Therapy n=42 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=63 Participants Patients receiving golimumab maintenance therapy
Faecal Calprotectin (μg/g)	46 ug/g Interval 5.0 to 2000.0	57 ug/g Interval 5.0 to 1260.0

SECONDARY outcome

Timeframe: Week 14 during induction therapy and at the point of study entry during maintenance

Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity

Outcome measures

Outcome measures
Measure	Golimumab Induction Therapy n=42 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=67 Participants Patients receiving golimumab maintenance therapy
Serum C-Reactive Protein (mg/L)	1 mg/L Interval 1.0 to 50.0	1 mg/L Interval 1.0 to 21.0

SECONDARY outcome

Timeframe: Week 14 during induction therapy and at the point of study entry during maintenance

Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab)

Outcome measures

Outcome measures
Measure	Golimumab Induction Therapy n=42 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=67 Participants Patients receiving golimumab maintenance therapy
Serum Albumin (g/L)	46 g/L Interval 33.0 to 52.0	47 g/L Interval 40.0 to 54.0

SECONDARY outcome

Timeframe: Week 14 during maintenance therapy and at the point of study entry during maintenance

Evaluated using Patient Reported Outcome 2 (PRO2). PRO2 ranges from 0-5 with higher scores denoting increasing clinical disease activity.

Outcome measures

Outcome measures
Measure	Golimumab Induction Therapy n=42 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=67 Participants Patients receiving golimumab maintenance therapy
Clinical UC Disease Activity	1 score on a scale Interval 0.0 to 5.0	0 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Week 14 during induction therapy and at the point of study entry during maintenance therapy

Evaluated using IBD-Control questionnaires. IBD-Control scores range from 0-16 with higher scores denoting better quality of life.

Outcome measures

Outcome measures
Measure	Golimumab Induction Therapy n=42 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=67 Participants Patients receiving golimumab maintenance therapy
Quality of Life (IBD-Control)	12.5 score on a scale Interval 0.0 to 16.0	14 score on a scale Interval 0.0 to 16.0

SECONDARY outcome

Timeframe: At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance

Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)

Outcome measures

Outcome measures
Measure	Golimumab Induction Therapy n=42 Participants Patients commencing golimumab	Golimumab Maintenance Therapy n=67 Participants Patients receiving golimumab maintenance therapy
Number of Patients With Detectable Anti-golimumab Antibodies	1 Participants	0 Participants

Adverse Events

Golimumab Induction Therapy

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Golimumab Maintenance Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Golimumab Induction Therapy n=42 participants at risk Patients commencing golimumab induction	Golimumab Maintenance Therapy n=70 participants at risk Patients receiving golimumab maintenance therapy
Musculoskeletal and connective tissue disorders Facet join injection	2.4% 1/42 • Number of events 1 • During the 14 week induction study for patients commencing treatment and at a single time point (the point of recruitment) for patients on maintenance therapy. Only serious adverse events (including all-cause mortality) were recorded. Non-serious adverse events were not recorded.	0.00% 0/70 • During the 14 week induction study for patients commencing treatment and at a single time point (the point of recruitment) for patients on maintenance therapy. Only serious adverse events (including all-cause mortality) were recorded. Non-serious adverse events were not recorded.
Hepatobiliary disorders Pancreatitis	2.4% 1/42 • Number of events 1 • During the 14 week induction study for patients commencing treatment and at a single time point (the point of recruitment) for patients on maintenance therapy. Only serious adverse events (including all-cause mortality) were recorded. Non-serious adverse events were not recorded.	0.00% 0/70 • During the 14 week induction study for patients commencing treatment and at a single time point (the point of recruitment) for patients on maintenance therapy. Only serious adverse events (including all-cause mortality) were recorded. Non-serious adverse events were not recorded.
Gastrointestinal disorders Ulcerative colitis flare requiring admission	4.8% 2/42 • Number of events 2 • During the 14 week induction study for patients commencing treatment and at a single time point (the point of recruitment) for patients on maintenance therapy. Only serious adverse events (including all-cause mortality) were recorded. Non-serious adverse events were not recorded.	0.00% 0/70 • During the 14 week induction study for patients commencing treatment and at a single time point (the point of recruitment) for patients on maintenance therapy. Only serious adverse events (including all-cause mortality) were recorded. Non-serious adverse events were not recorded.

Other adverse events

Adverse event data not reported

Additional Information

Dr Mark Samaan

Guy's & St Thomas' Hospital

Phone: 07740637713

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place