Trial Outcomes & Findings for Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis (NCT NCT02919761)

NCT ID: NCT02919761

Last Updated: 2020-03-31

Results Overview

LDA is defined as DAS28 \<3.2.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 259 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2020-03-31

Participant Flow

A total of 259 patients were recruited at 80 study centers globally for Part 1. Of those participants, 77 were randomized to receive Acthar and 77 were randomized to receive Placebo for an additional 12 weeks, which was Part 2.

All participants enrolled in Part 1

Participant milestones

Measure	All Enrolled Participants All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive 1 mL Acthar Gel twice weekly during Part 2, from Week 12 through Week 24	Part 2: Placebo Participants receive 1 mL placebo twice weekly during Part 2, from Week 12 through Week 24
Part 1: Open Label STARTED	259	0	0
Part 1: Open Label mITT Population	259	0	0
Part 1: Open Label Safety Population	259	0	0
Part 1: Open Label Per Protocol Population	236	0	0
Part 1: Open Label COMPLETED	235	0	0
Part 1: Open Label NOT COMPLETED	24	0	0
Part 2: Double-blind STARTED	0	77	77
Part 2: Double-blind Safety Population	0	77	77
Part 2: Double-blind mITT Population	0	77	76
Part 2: Double-blind Per Protocol Population	0	76	73
Part 2: Double-blind COMPLETED	0	71	56
Part 2: Double-blind NOT COMPLETED	0	6	21

Reasons for withdrawal

Measure	All Enrolled Participants All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive 1 mL Acthar Gel twice weekly during Part 2, from Week 12 through Week 24	Part 2: Placebo Participants receive 1 mL placebo twice weekly during Part 2, from Week 12 through Week 24
Part 1: Open Label Withdrawal by Subject	12	0	0
Part 1: Open Label Adverse Event	1	0	0
Part 1: Open Label Lost to Follow-up	1	0	0
Part 1: Open Label Met withdrawal criteria	5	0	0
Part 1: Open Label Did Not Achieve Lda At Week 12	2	0	0
Part 1: Open Label Dose Greater Than 20mg/Week	1	0	0
Part 1: Open Label did not meet inclusion criteria 8	1	0	0
Part 1: Open Label Termination by Sponsor	1	0	0
Part 2: Double-blind Withdrawal by Subject	0	0	2
Part 2: Double-blind Adverse Event	0	1	0
Part 2: Double-blind Lost to Follow-up	0	0	3
Part 2: Double-blind Met withdrawal criteria	0	1	2
Part 2: Double-blind Worsening of disease activity	0	4	10
Part 2: Double-blind Did not meet LDA at Week 16	0	0	1
Part 2: Double-blind Did not meet LDA at Week 20	0	0	1
Part 2: Double-blind Discontinued exclusion 16	0	0	2

Baseline Characteristics

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Part 1: All Participants Enrolled n=259 Participants All participants who enrolled in the trial
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	231 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	213 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	40 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants
Race (NIH/OMB) White	170 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: modified Intent to Treat (mITT) Population

LDA is defined as DAS28 <3.2.

Outcome measures

Measure	Part 1: All Participants Enrolled n=259 Participants All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit at Baseline	0 Participants	—
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit at Week 4	17 Participants	—
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit at Week 8	37 Participants	—
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit at Week 12	163 Participants	—

PRIMARY outcome

Timeframe: Week 12 to Week 24

Population: mITT Population

Low disease activity is defined as DAS28 <3.2.

Outcome measures

Measure	Part 1: All Participants Enrolled n=77 Participants All participants who enrolled in the trial	Part 2: Acthar Gel n=76 Participants Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit at Week 24	47 Participants	32 Participants
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit at Week 12	77 Participants	75 Participants
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit at Week 16	58 Participants	53 Participants
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit at Week 20	61 Participants	48 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: mITT

The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)

The DAS28 is a composite score derived from the following assessments:

• Swollen Joint Count
• Tender Joint Count
• Patient's Global Health
• Erythrocyte Sedimentation Rate

Outcome measures

Measure	Part 1: All Participants Enrolled n=28 Joints All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 1: Swollen Joint Count by Visit at Baseline	10.9 Count of swollen joints Standard Deviation 5.37	—
Part 1: Swollen Joint Count by Visit at Week 4	5.6 Count of swollen joints Standard Deviation 4.88	—
Part 1: Swollen Joint Count by Visit at Week 8	4.0 Count of swollen joints Standard Deviation 4.36	—
Part 1: Swollen Joint Count by Visit at Week 12	2.8 Count of swollen joints Standard Deviation 4.26	—

SECONDARY outcome

Timeframe: Baseline, Week 12 to Week 24

Population: mITT Population

The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28)

The DAS28 is a composite score derived from the following assessments:

• Swollen Joint Count
• Tender Joint Count
• Patient's Global Health
• Erythrocyte Sedimentation Rate

Outcome measures

Measure	Part 1: All Participants Enrolled n=28 Joints All participants who enrolled in the trial	Part 2: Acthar Gel n=28 Joints Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 2: Swollen Joint Count by Visit During Part 2 at Baseline	10.1 Count of swollen joints Standard Deviation 4.87	9.7 Count of swollen joints Standard Deviation 4.32
Part 2: Swollen Joint Count by Visit During Part 2 at Week 12	0.9 Count of swollen joints Standard Deviation 1.09	0.9 Count of swollen joints Standard Deviation 1.03
Part 2: Swollen Joint Count by Visit During Part 2 at Week 16	1.7 Count of swollen joints Standard Deviation 3.08	1.1 Count of swollen joints Standard Deviation 1.31
Part 2: Swollen Joint Count by Visit During Part 2 at Week 20	1.9 Count of swollen joints Standard Deviation 3.62	0.9 Count of swollen joints Standard Deviation 1.19
Part 2: Swollen Joint Count by Visit During Part 2 at Week 24	2.3 Count of swollen joints Standard Deviation 3.71	1.5 Count of swollen joints Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: mITT Population

The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)

The DAS28 is a composite score derived from the following assessments:

• Swollen Joint Count
• Tender Joint Count
• Patient's Global Health
• Erythrocyte Sedimentation Rate

Outcome measures

Measure	Part 1: All Participants Enrolled n=28 Joints All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 1: Tender Joint Count by Visit at Baseline	14.7 Count of Tender Joints Standard Deviation 7.08	—
Part 1: Tender Joint Count by Visit at Week 4	7.7 Count of Tender Joints Standard Deviation 6.39	—
Part 1: Tender Joint Count by Visit at Week 8	5.7 Count of Tender Joints Standard Deviation 5.93	—
Part 1: Tender Joint Count by Visit at Week 12	3.9 Count of Tender Joints Standard Deviation 5.69	—

SECONDARY outcome

Timeframe: Baseline, Week 12 to Week 24

Population: mITT Population

The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)

The DAS28 is a composite score derived from the following assessments:

• Swollen Joint Count
• Tender Joint Count
• Patient's Global Health
• Erythrocyte Sedimentation Rate

Outcome measures

Measure	Part 1: All Participants Enrolled n=28 Joints All participants who enrolled in the trial	Part 2: Acthar Gel n=28 Joints Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 2: Tender Joint Count by Visit at Baseline	13.5 Count of Tender Joints Standard Deviation 7.24	13.5 Count of Tender Joints Standard Deviation 6.41
Part 2: Tender Joint Count by Visit at Week 12	1.5 Count of Tender Joints Standard Deviation 1.33	1.4 Count of Tender Joints Standard Deviation 1.24
Part 2: Tender Joint Count by Visit at Week 16	2.6 Count of Tender Joints Standard Deviation 3.96	1.6 Count of Tender Joints Standard Deviation 1.47
Part 2: Tender Joint Count by Visit at Week 20	2.7 Count of Tender Joints Standard Deviation 4.36	1.5 Count of Tender Joints Standard Deviation 1.67
Part 2: Tender Joint Count by Visit at Week 24	3.1 Count of Tender Joints Standard Deviation 4.46	2.4 Count of Tender Joints Standard Deviation 4.29

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: mITT Population

Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.

A lower score indicates better general health.

Outcome measures

Measure	Part 1: All Participants Enrolled n=259 Participants All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 1: Patient-Reported General Health by Visit at Baseline	59.8 mm Standard Deviation 20.02	—
Part 1: Patient-Reported General Health by Visit at Week 4	45.1 mm Standard Deviation 23.15	—
Part 1: Patient-Reported General Health by Visit at Week 8	37.8 mm Standard Deviation 22.95	—
Part 1: Patient-Reported General Health by Visit at Week 12	27.0 mm Standard Deviation 22.18	—

SECONDARY outcome

Timeframe: Baseline, Week 12 to Week 24

Population: mITT Population

Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.

A lower score indicates better general health.

Outcome measures

Measure	Part 1: All Participants Enrolled n=76 Participants All participants who enrolled in the trial	Part 2: Acthar Gel n=77 Participants Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 2: Patient-Reported General Health by Visit at Baseline	13.5 mm Standard Deviation 7.24	13.5 mm Standard Deviation 6.41
Part 2: Patient-Reported General Health by Visit at Week 12	15.4 mm Standard Deviation 14.47	18.8 mm Standard Deviation 14.34
Part 2: Patient-Reported General Health by Visit at Week 16	17.2 mm Standard Deviation 18.16	19.6 mm Standard Deviation 17.98
Part 2: Patient-Reported General Health by Visit at Week 20	18.5 mm Standard Deviation 20.14	17.9 mm Standard Deviation 16.04
Part 2: Patient-Reported General Health by Visit at Week 24	21.4 mm Standard Deviation 22.56	21.3 mm Standard Deviation 21.28

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: mITT Population

The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.

The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).

The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.

The ESR is a common test for inflammation and used to derive the DAS28.

The DAS28 is a composite score derived from the following assessments:

• Swollen Joint Count
• Tender Joint Count
• Patient's Global Health
• Erythrocyte Sedimentation Rate

Outcome measures

Measure	Part 1: All Participants Enrolled n=259 Participants All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit at Baseline	43.6 mm/hr Standard Deviation 24.77	—
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit at Week 4	35.4 mm/hr Standard Deviation 23.04	—
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit at Week 8	30.6 mm/hr Standard Deviation 21.24	—
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit at Week 12	24.0 mm/hr Standard Deviation 21.54	—

SECONDARY outcome

Timeframe: Baseline, Week 12 to Week 24

Population: mITT Population

The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.

The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).

The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.

The ESR is a common test for inflammation and used to derive the DAS28.

The DAS28 is a composite score derived from the following assessments:

• Swollen Joint Count
• Tender Joint Count
• Patient's Global Health
• Erythrocyte Sedimentation Rate

Outcome measures

Measure	Part 1: All Participants Enrolled n=76 Participants All participants who enrolled in the trial	Part 2: Acthar Gel n=77 Participants Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit at Baseline	42.2 mm/hr Standard Deviation 23.05	40.3 mm/hr Standard Deviation 21.47
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit at Week 12	15.2 mm/hr Standard Deviation 12.669	15.8 mm/hr Standard Deviation 12.21
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit at Week 16	19.6 mm/hr Standard Deviation 14.62	17.7 mm/hr Standard Deviation 14.42
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit at Week 20	22.0 mm/hr Standard Deviation 17.75	17.5 mm/hr Standard Deviation 13.67
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit at Week 24	25.1 mm/hr Standard Deviation 18.81	23.1 mm/hr Standard Deviation 16.56

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: mITT Population

Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.

Outcome measures

Measure	Part 1: All Participants Enrolled n=259 Participants All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 1: Patient's Global Assessment of Pain by Visit at Baseline	64.9 mm Standard Deviation 20.36	—
Part 1: Patient's Global Assessment of Pain by Visit at Week 4	44.1 mm Standard Deviation 23.78	—
Part 1: Patient's Global Assessment of Pain by Visit at Week 8	37.3 mm Standard Deviation 22.92	—
Part 1: Patient's Global Assessment of Pain by Visit at Week 12	27.5 mm Standard Deviation 23.02	—

SECONDARY outcome

Timeframe: Baseline, Week 12 to Week 24

Population: mITT Population

Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.

Outcome measures

Measure	Part 1: All Participants Enrolled n=76 Participants All participants who enrolled in the trial	Part 2: Acthar Gel n=77 Participants Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 2: Patient's Global Assessment of Pain by Visit at Week 20	20.0 mm Standard Deviation 20.21	19.8 mm Standard Deviation 16.23
Part 2: Patient's Global Assessment of Pain by Visit at Baseline	62.8 mm Standard Deviation 21.02	65.7 mm Standard Deviation 18.65
Part 2: Patient's Global Assessment of Pain by Visit at Week 12	17.0 mm Standard Deviation 16.00	18.9 mm Standard Deviation 16.64
Part 2: Patient's Global Assessment of Pain by Visit at Week 16	21.6 mm Standard Deviation 21.72	22.1 mm Standard Deviation 20.77
Part 2: Patient's Global Assessment of Pain by Visit at Week 24	22.1 mm Standard Deviation 20.50	21.8 mm Standard Deviation 19.70

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: mITT Population

The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.

Outcome measures

Measure	Part 1: All Participants Enrolled n=259 Participants All participants who enrolled in the trial	Part 2: Acthar Gel Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 1: Physician's Global Assessment of Disease Activities by Visit at Baseline	64.3 mm Standard Deviation 14.93	—
Part 1: Physician's Global Assessment of Disease Activities by Visit at Week 4	36.1 mm Standard Deviation 18.90	—
Part 1: Physician's Global Assessment of Disease Activities by Visit at Week 8	29.0 mm Standard Deviation 18.92	—
Part 1: Physician's Global Assessment of Disease Activities by Visit at Week 12	21.0 mm Standard Deviation 19.49	—

SECONDARY outcome

Timeframe: Week 12 to Week 24

Population: mITT Population

The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.

Outcome measures

Measure	Part 1: All Participants Enrolled n=77 Participants All participants who enrolled in the trial	Part 2: Acthar Gel n=77 Participants Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24
Part 2: Physician's Global Assessment of Disease Activities by Visit at Week 12	11.5 mm Standard Deviation 8.91	12.9 mm Standard Deviation 11.49
Part 2: Physician's Global Assessment of Disease Activities by Visit at Week 16	15.5 mm Standard Deviation 15.57	13.3 mm Standard Deviation 13.78
Part 2: Physician's Global Assessment of Disease Activities by Visit at Week 20	15.9 mm Standard Deviation 16.25	12.4 mm Standard Deviation 8.61
Part 2: Physician's Global Assessment of Disease Activities by Visit at Week 24	17.8 mm Standard Deviation 18.12	15.2 mm Standard Deviation 16.84

Adverse Events

Part 1: All Participants Enrolled

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Part 2: Placebo

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Part 2: Acthar Gel

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: All Participants Enrolled n=259 participants at risk All participants enrolled in the trial with AEs during Part 1	Part 2: Placebo n=77 participants at risk Participants who received Placebo in Part 2 with AEs during Part 2	Part 2: Acthar Gel n=77 participants at risk Participants who received Acthar Gel in Part 2 with AEs during Part 2
General disorders Chest pain	0.39% 1/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Infections and infestations Pneumonia	0.39% 1/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Injury, poisoning and procedural complications Craniocerebral injury	0.39% 1/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug

Other adverse events

Measure	Part 1: All Participants Enrolled n=259 participants at risk All participants enrolled in the trial with AEs during Part 1	Part 2: Placebo n=77 participants at risk Participants who received Placebo in Part 2 with AEs during Part 2	Part 2: Acthar Gel n=77 participants at risk Participants who received Acthar Gel in Part 2 with AEs during Part 2
Infections and infestations Urinary tract infection	3.9% 10/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	3.9% 3/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Infections and infestations Pharyngitis	2.7% 7/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Nervous system disorders Headache	3.5% 9/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	6.5% 5/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	6.5% 5/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Infections and infestations Nasopharyngitis	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Infections and infestations Upper respiratory tract infection	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	3.9% 3/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Infections and infestations Rhinitis	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Gastrointestinal disorders Diarrhoea	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	3.9% 3/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	1.3% 1/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Gastrointestinal disorders Gastritis	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	1.3% 1/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	3.9% 3/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Investigations Glycosylated haemoglobin increased	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	1.3% 1/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Blood and lymphatic system disorders Anaemia	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	2.6% 2/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug
Vascular disorders Hypertension	0.00% 0/259 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	0.00% 0/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug	3.9% 3/77 • Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug

Additional Information

Medical Information Call Center

Mallinckrodt

Phone: 800-556-3314

Email: clinicaltrials@mnk.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place