Trial Outcomes & Findings for Spondylitis Trial of Apremilast for Better Rheumatic Therapy (NCT NCT00944658)

Results Overview

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2019-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo placebo twice a day for 12 weeks, 4 weeks follow up Placebo (sugar pill): twice a day	Apremilast 30 mg twice a day for 12 weeks, 4 weeks follow up Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
Treatment 12 Weeks STARTED	19	19
Treatment 12 Weeks COMPLETED	19	17
Treatment 12 Weeks NOT COMPLETED	0	2
Follow up 4 Weeks STARTED	19	17
Follow up 4 Weeks COMPLETED	19	17
Follow up 4 Weeks NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo placebo twice a day for 12 weeks, 4 weeks follow up Placebo (sugar pill): twice a day	Apremilast 30 mg twice a day for 12 weeks, 4 weeks follow up Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
Treatment 12 Weeks Adverse Event	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=19 Participants placebo twice a day for 12 weeks, 4 weeks follow up Placebo (sugar pill): twice a day	Apremilast n=17 Participants 30 mg twice a day for 12 weeks, 4 weeks follow up Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks	Total n=36 Participants Total of all reporting groups
Age, Continuous	39.21 years STANDARD_DEVIATION 13.3 • n=19 Participants	44.88 years STANDARD_DEVIATION 11.1 • n=17 Participants	42.95 years STANDARD_DEVIATION 11.01 • n=36 Participants
Sex: Female, Male Female	2 Participants n=19 Participants	2 Participants n=17 Participants	4 Participants n=36 Participants
Sex: Female, Male Male	17 Participants n=19 Participants	15 Participants n=17 Participants	32 Participants n=36 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	19 participants n=19 Participants	17 participants n=17 Participants	36 participants n=36 Participants
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	4.36 units on a scale STANDARD_DEVIATION 1.75 • n=19 Participants	4.79 units on a scale STANDARD_DEVIATION 2.16 • n=17 Participants	4.57 units on a scale STANDARD_DEVIATION 1.95 • n=36 Participants
Bath Ankylosing Spondylitis Functional Index (BASFI)	3.19 units on a scale STANDARD_DEVIATION 2.2 • n=19 Participants	4.55 units on a scale STANDARD_DEVIATION 2.42 • n=17 Participants	3.87 units on a scale STANDARD_DEVIATION 2.31 • n=36 Participants
CRP C-reactive protein	6.24 mg/dl STANDARD_DEVIATION 2.56 • n=19 Participants	11.37 mg/dl STANDARD_DEVIATION 12.12 • n=17 Participants	8.8 mg/dl STANDARD_DEVIATION 7.34 • n=36 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants placebo twice a day for 12 weeks, 4 weeks follow up Placebo (sugar pill): twice a day	Apremilast n=17 Participants 30 mg twice a day for 12 weeks, 4 weeks follow up Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
Changes of Apremilast in Patients With AS, Changes in BASDAI Score From Baseline	-0.77 units on a scale Standard Deviation 1.47	-1.59 units on a scale Standard Deviation 1.48

PRIMARY outcome

Timeframe: Baseline and 12 weeks

This endpoint the night time pain score change was recorded by questionnaire to evaluate the Apremilast effect on symptom, higher reduction better improvement. scale is 0-10

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants placebo twice a day for 12 weeks, 4 weeks follow up Placebo (sugar pill): twice a day	Apremilast n=17 Participants 30 mg twice a day for 12 weeks, 4 weeks follow up Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
Changes of Apremilast on the Signs and Symptoms of AS, Night Pain From Baseline	-0.23 score on a scale Standard Deviation 2.75	-0.81 score on a scale Standard Deviation 3.01

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Bath Ankylosing Spondylitis Functional Index (BASFI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants placebo twice a day for 12 weeks, 4 weeks follow up Placebo (sugar pill): twice a day	Apremilast n=17 Participants 30 mg twice a day for 12 weeks, 4 weeks follow up Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
Effect of Apremilast in Patients With AS, Changes in BASFI Score	-0.28 units on a scale Standard Deviation 1.61	-1.74 units on a scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: 16 weeks

To evaluate the safety and tolerability of Apremilast in AS, the investigator recorded the incidence of adverse events.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants placebo twice a day for 12 weeks, 4 weeks follow up Placebo (sugar pill): twice a day	Apremilast n=19 Participants 30 mg twice a day for 12 weeks, 4 weeks follow up Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
The Safety and Tolerability of Apremilast in AS, Number of Participants With Adverse Events	17 Participants	18 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Apremilast

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=19 participants at risk placebo twice a day for 12 weeks, 4 weeks follow up Placebo (sugar pill): twice a day	Apremilast n=19 participants at risk 30 mg twice a day for 12 weeks, 4 weeks follow up Apremilast: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
Nervous system disorders Headache	26.3% 5/19 • Number of events 5 • 16 weeks	42.1% 8/19 • Number of events 8 • 16 weeks
Infections and infestations Upper respiratory tract infection	31.6% 6/19 • Number of events 6 • 16 weeks	31.6% 6/19 • Number of events 6 • 16 weeks
Gastrointestinal disorders Loose stools	10.5% 2/19 • Number of events 2 • 16 weeks	26.3% 5/19 • Number of events 5 • 16 weeks
Gastrointestinal disorders Nausea	15.8% 3/19 • Number of events 3 • 16 weeks	15.8% 3/19 • Number of events 3 • 16 weeks
Gastrointestinal disorders Flatulance	0.00% 0/19 • 16 weeks	10.5% 2/19 • Number of events 2 • 16 weeks
Blood and lymphatic system disorders raised serum amylase	0.00% 0/19 • 16 weeks	10.5% 2/19 • Number of events 2 • 16 weeks
Gastrointestinal disorders Diarrhoe	10.5% 2/19 • Number of events 2 • 16 weeks	10.5% 2/19 • Number of events 2 • 16 weeks

Additional Information

Peter Taylor

Imperial College London

Phone: +44 (0) 2075941872

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place