Trial Outcomes & Findings for The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis (NCT NCT00573157)
NCT ID: NCT00573157
Last Updated: 2016-03-23
Results Overview
Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate \[GFR\]), improvement in proteinuria (urine protein/creatinine ratio \<0.5) \& resolution of hematuria. Partial response (PR): from baseline, a \<= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) \& resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
6 participants
Primary outcome timeframe
At Week 52
Results posted on
2016-03-23
Participant Flow
Participant milestones
| Measure |
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids
Atacicept was administered subcutaneously (SC) at a loading dose of 150 milligram (mg) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose corticosteroids (CS) of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids
Atacicept was administered subcutaneously (SC) at a loading dose of 150 milligram (mg) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose corticosteroids (CS) of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
Baseline characteristics by cohort
| Measure |
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids
n=4 Participants
Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
n=2 Participants
Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 25.5 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 52Population: Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.
Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate \[GFR\]), improvement in proteinuria (urine protein/creatinine ratio \<0.5) \& resolution of hematuria. Partial response (PR): from baseline, a \<= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) \& resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 52Population: Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 52Population: Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.
Outcome measures
Outcome data not reported
Adverse Events
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids
n=4 participants at risk
Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
n=2 participants at risk
Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Nervous system disorders
Syncope
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Infections and infestations
Empyema
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Infections and infestations
Pneumonia legionella
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Renal and urinary disorders
Renal failure acute
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Vascular disorders
Hypertensive crisis
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
Other adverse events
| Measure |
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids
n=4 participants at risk
Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
n=2 participants at risk
Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator's discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
General disorders
Injection site erythema
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
General disorders
Injection site haematoma
|
0.00%
0/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
General disorders
Injection site pain
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
General disorders
Oedema
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
2/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
50.0%
2/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Acne
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
50.0%
1/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Investigations
Blood immunoglobulin G decreased
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Psychiatric disorders
Mood altered
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Renal and urinary disorders
Renal failure acute
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
0.00%
0/2 • From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publishing results, Institution and Principal Investigator (PI) must first provide Sponsor with a copy of proposed publication for review at least 30 days prior to submission. If Institution and PI do not agree to modification, they shall so notify Sponsor and postpone submission for additional 60 days to allow Sponsor to seek legal remedies or file patent applications. There is a need for coordinated approach to any publication of results from sites for any multi-site study.
- Publication restrictions are in place
Restriction type: OTHER