Trial Outcomes & Findings for Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE) (NCT NCT01781611)

Last Updated: 2020-11-25

Results Overview

This is a landmark measure of percentage of patients who meet response criteria. To meet the BICLA response measure a patient must, compared to baseline, have a decrease in all moderate or severe scores on the British Isles Lupus Assessment Group (BILAG) index by at least one severity grade (Severe disease (BILAG A score) must drop to at least moderate (B or better) and B must drop to at least mild (C or not present). Also, there must be no increase in any other BILAG organ scores, no increase in The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, and no increase in the physician's global assessment (PGA) by more than 10% of the scale. Furthermore, there may no off protocol medication increases. Note on all scales mentioned a higher score signifies greater disease activity. Ranges on BILAG could be 0-108 but are rarely greater than 36. SLEDAI could range 0-105 but is rarely greater than 20. PGA 0-100 but rarely greater than 76.

Recruitment status

TERMINATED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-11-25

Participant Flow

All patients were recruited from the Oklahoma Medical Research Foundation clinic after a full informed consent process.

There were no pre-assignment restrictions or procedures.

Participant milestones

Participant milestones
Measure	Extended Release Dipyridamole/Aspirin extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks	Aspirin half a tablet of a 81mg aspirin twice daily for 24 weeks 81mg aspirin: half a tablet twice daily for 24 weeks
Overall Study STARTED	13	5
Overall Study COMPLETED	9	5
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Extended Release Dipyridamole/Aspirin extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks	Aspirin half a tablet of a 81mg aspirin twice daily for 24 weeks 81mg aspirin: half a tablet twice daily for 24 weeks
Overall Study Adverse Event	4	0

Baseline Characteristics

Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extended Release Dipyridamole/Aspirin n=13 Participants extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks	Aspirin n=5 Participants half a tablet of a 81mg aspirin twice daily for 24 weeks 81mg aspirin: half a tablet twice daily for 24 weeks	Total n=18 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 12.0 • n=5 Participants	43.8 years STANDARD_DEVIATION 12.9 • n=7 Participants	44.3 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	5 participants n=7 Participants	18 participants n=5 Participants
Mean BILAG Score at Entry	11.2 units on a scale STANDARD_DEVIATION 4.4 • n=5 Participants	10 units on a scale STANDARD_DEVIATION 4.9 • n=7 Participants	10.9 units on a scale STANDARD_DEVIATION 4.4 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Full Analysis Set was analyzed including all randomized patients

Outcome measures

Outcome measures
Measure	Extended Release Dipyridamole/Aspirin n=13 Participants extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks	Aspirin n=5 Participants half a tablet of a 81mg aspirin twice daily for 24 weeks 81mg aspirin: half a tablet twice daily for 24 weeks
British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA)	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set of all randomized patients

This is a landmark analysis of percentage of patients who meet the following response criteria: Compared to baseline there must be a 4 point decrease in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), no increase in The British Isles Lupus Assessment Group (BILAG) Index score and no more of an increase in Physician's Global Assessment (PGA) than 10% of the scale. As assessed here, there must also be no off protocol increase in medications. All scales signify worsening disease when scores increase. Ranges on BILAG could be 0-108 but are rarely greater than 36. SLEDAI could range 0-105 but is rarely greater than 20. PGA 0-100 but rarely greater than 76.

Outcome measures

Outcome measures
Measure	Extended Release Dipyridamole/Aspirin n=13 Participants extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks	Aspirin n=5 Participants half a tablet of a 81mg aspirin twice daily for 24 weeks 81mg aspirin: half a tablet twice daily for 24 weeks
Systemic Lupus Erythematosus Responder Index (SRI) 4	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Full Analysis Set of all randomized patients

This is a landmark analysis of percentage of patients who, compared to baseline, have a 4 point drop in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). A 4 point decrease signifies a clinically significant decrease in disease activity as reported in many studies and as commonly used as a clinical endpoint in trials. SLEDAI could range 0-105 but is rarely greater than 20.

Outcome measures

Outcome measures
Measure	Extended Release Dipyridamole/Aspirin n=13 Participants extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks	Aspirin n=5 Participants half a tablet of a 81mg aspirin twice daily for 24 weeks 81mg aspirin: half a tablet twice daily for 24 weeks
SRI Component Analyses: 4 Point Drop in SLEDAI	4 Participants	2 Participants

Adverse Events

Extended Release Dipyridamole/Aspirin

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Aspirin

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Extended Release Dipyridamole/Aspirin n=13 participants at risk extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks	Aspirin n=5 participants at risk half a tablet of a 81mg aspirin twice daily for 24 weeks 81mg aspirin: half a tablet twice daily for 24 weeks
Reproductive system and breast disorders Hysterectomy	0.00% 0/13 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	20.0% 1/5 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.

Other adverse events

Additional Information

Joan T. Merrill, M.D.

Oklahoma Medical Research Foundation

Phone: 405-822-2336

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Extended Release Dipyridamole/Aspirin n=13 participants at risk extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks extended release dipyridamole 200mg/aspirin 25mg: one tablet twice daily for 24 weeks	Aspirin n=5 participants at risk half a tablet of a 81mg aspirin twice daily for 24 weeks 81mg aspirin: half a tablet twice daily for 24 weeks
Gastrointestinal disorders Gastroenteritis	61.5% 8/13 • Number of events 12 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	60.0% 3/5 • Number of events 3 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Infections and infestations Upper Respiratory Infection	7.7% 1/13 • Number of events 2 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	60.0% 3/5 • Number of events 3 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Infections and infestations Urinary Tract Infection	23.1% 3/13 • Number of events 3 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	40.0% 2/5 • Number of events 2 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Nervous system disorders Headache	30.8% 4/13 • Number of events 4 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	20.0% 1/5 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	20.0% 1/5 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Nervous system disorders Dizziness	0.00% 0/13 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	20.0% 1/5 • Number of events 4 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Injury, poisoning and procedural complications Spider Bite	0.00% 0/13 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	40.0% 2/5 • Number of events 2 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Renal and urinary disorders Bladder Outlet Obstruction	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Musculoskeletal and connective tissue disorders Chest Pain	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Infections and infestations Chlamydia infectoin	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Gastrointestinal disorders Colitis	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Immune system disorders herpes zoster	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Musculoskeletal and connective tissue disorders Muscle Cramp	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Infections and infestations Paronychia	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Immune system disorders neuralgia	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Nervous system disorders Sleep Disorder	7.7% 1/13 • Number of events 2 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Immune system disorders urticaria	15.4% 2/13 • Number of events 2 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
Musculoskeletal and connective tissue disorders sprained ankle	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.
General disorders weight loss	7.7% 1/13 • Number of events 1 • 6 months All adverse events were recorded in the medical record and compiled for analysis.	0.00% 0/5 • 6 months All adverse events were recorded in the medical record and compiled for analysis.