Trial Outcomes & Findings for A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica (NCT NCT01364389)
NCT ID: NCT01364389
Last Updated: 2021-09-17
Results Overview
The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline, Day 15
Results posted on
2021-09-17
Participant Flow
Participant milestones
| Measure |
ACZ885
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
5
|
|
Overall Study
Pharmacodynamic (PD) Analysis Set
|
5
|
6
|
4
|
|
Overall Study
COMPLETED
|
3
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
ACZ885
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Protocol deviation
|
0
|
0
|
1
|
|
Overall Study
Administrative problems
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
Baseline characteristics by cohort
| Measure |
ACZ885
n=5 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=6 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=5 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 9.09 • n=99 Participants
|
68.8 years
STANDARD_DEVIATION 8.61 • n=107 Participants
|
69.4 years
STANDARD_DEVIATION 7.89 • n=206 Participants
|
68.5 years
STANDARD_DEVIATION 8.02 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 15Population: Pharmacodynamic (PD) Analysis Set: This set included participants who received at least one dose of study medication and had no major protocol deviation that may impact the PD data.
The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants.
Outcome measures
| Measure |
ACZ885
n=3 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=6 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=4 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Polymyalgia Rheumatica Activity Score (PMR-AS)
|
64.5 Percent reduction
Standard Error 0.68
|
51.7 Percent reduction
Standard Error 0.47
|
91.9 Percent reduction
Standard Error 86.2
|
SECONDARY outcome
Timeframe: Day 15Population: PD analysis set
The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had: \>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness \< 60 minutes.
Outcome measures
| Measure |
ACZ885
n=5 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=6 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=4 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Time to Partial Clinical Response
|
20.0 Percentage of participants
|
16.7 Percentage of participants
|
75.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15Population: PD analysis set
The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: \>70% reduction in patient global assessment VAS compared with baseline, morning stiffness \< 30 min, CRP \< 1.0 mg/dL and/or ESR \< 30 mm/1st hr.
Outcome measures
| Measure |
ACZ885
n=5 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=6 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=4 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Time to Complete Clinical Response
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44
Outcome measures
| Measure |
ACZ885
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=1 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Time to First Flare
|
—
|
44 Days
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
Outcome measures
| Measure |
ACZ885
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=1 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Number of Flares Over a 6 Month Period
|
—
|
1 Participant
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
Outcome measures
| Measure |
ACZ885
n=3 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=4 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=4 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Mean Steroid Dose Over a 6 Month Period
|
276.8 Number of doses
Standard Deviation 46.34
|
256.7 Number of doses
Standard Deviation 27.89
|
428.9 Number of doses
Standard Deviation 131.44
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Safety analysis set: This set included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
ACZ885
n=5 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=6 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=5 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths
Adverse Events (serious and non-serious)
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: One participant experienced one flare after initial dose but this participant had no flare after a redose. This patient was in the AIN457 arm.
One participant experienced one flare after initial dose but this participant had no flare after a redose. This patient was in the AIN457 arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
The Short Form-36 (SF-36) Questionnaire is a 36-item questionnaire yields an 8-scale health profile as well as summary measures of individual patients.. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health.
Outcome measures
| Measure |
ACZ885
n=5 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=6 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=4 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire
Physical component score at baseline
|
26.126 Scores on a scale
Standard Deviation 8.1517
|
29.009 Scores on a scale
Standard Deviation 4.3115
|
27.001 Scores on a scale
Standard Deviation 5.2561
|
|
Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire
Physical component score at EOS / Month 6 (n=4,6,2)
|
44.293 Scores on a scale
Standard Deviation 12.6038
|
48.496 Scores on a scale
Standard Deviation 8.2306
|
34.544 Scores on a scale
Standard Deviation 7.7632
|
|
Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire
Mental component score at baseline
|
30.490 Scores on a scale
Standard Deviation 11.2875
|
35.779 Scores on a scale
Standard Deviation 5.9113
|
29.673 Scores on a scale
Standard Deviation 6.1925
|
|
Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire
Mental component score at month 6 / EOS (n=4,6,2)
|
44.668 Scores on a scale
Standard Deviation 20.3716
|
54.136 Scores on a scale
Standard Deviation 8.8815
|
55.233 Scores on a scale
Standard Deviation 2.8274
|
SECONDARY outcome
Timeframe: baseline and at month 6Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability.
Outcome measures
| Measure |
ACZ885
n=5 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=6 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=4 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ)
standard disability score at baseline
|
1.900 Scores on a scale
Standard Deviation 0.6869
|
1.646 Scores on a scale
Standard Deviation 0.2896
|
2.063 Scores on a scale
Standard Deviation 0.2394
|
|
Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ)
standard disability score at EOS / Month 6 (n=4,6,3)
|
0.719 Scores on a scale
Standard Deviation 1.0225
|
0.188 Scores on a scale
Standard Deviation 0.3513
|
0.958 Scores on a scale
Standard Deviation 0.3819
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability.
Outcome measures
| Measure |
ACZ885
n=4 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=6 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
n=3 Participants
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6
|
-68.06 Percentage
Standard Deviation 36.781
|
-86.83 Percentage
Standard Deviation 25.478
|
-54.04 Percentage
Standard Deviation 12.296
|
SECONDARY outcome
Timeframe: Day 15Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurement for the outcome measure.
Outcome measures
| Measure |
ACZ885
n=4 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=3 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Pharmacokinetics of AIN457 and ACZ885 - Cmax
|
69.9 microgram/mL
Standard Deviation 5.58
|
46.8 microgram/mL
Standard Deviation 2.85
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurement for the outcome measure.
Outcome measures
| Measure |
ACZ885
n=4 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=3 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Pharmacokinetics of AIN457 and ACZ885 - Tmax
|
0.0868 days
Interval 0.0833 to 1.97
|
0.107 days
Interval 0.0868 to 0.167
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
Outcome measures
| Measure |
ACZ885
n=3 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=2 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast
AUCinf (microg/day/mL)
|
1570 microg/day/mL
Standard Deviation 80
|
1260 microg/day/mL
Standard Deviation 134
|
—
|
|
Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast
AUClast (microg/day/mL)
|
1560 microg/day/mL
Standard Deviation 74.7
|
1200 microg/day/mL
Standard Deviation 132
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
Outcome measures
| Measure |
ACZ885
n=3 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=2 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Pharmacokinetics of AIN457 and ACZ885 - CL
|
0.171 L/day
Standard Deviation 0.440
|
0.157 L/day
Standard Deviation 0.0106
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
Outcome measures
| Measure |
ACZ885
n=3 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=2 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Pharmacokinetics of AIN457 and ACZ885 - Vz
|
6.49 L
Standard Deviation 1.19
|
9.85 L
Standard Deviation 1.29
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
Outcome measures
| Measure |
ACZ885
n=3 Participants
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457
n=4 Participants
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Pharmacokinetics of AIN457 and ACZ885 - T1/2
|
26.6 Day
Standard Deviation 2.38
|
40.2 Day
Standard Deviation 4.47
|
—
|
Adverse Events
ACZ885 3mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AIN457 3mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Prednisone 20mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACZ885 3mg/kg
n=5 participants at risk
On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
AIN457 3mg/kg
n=6 participants at risk
On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
|
Prednisone 20mg
n=5 participants at risk
On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Gastrointestinal disorders
Toothache
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Investigations
Blood pressure increased
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Investigations
Weight increased
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Musculoskeletal and connective tissue disorders
Seronegative arthritis
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 239 days
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER