Trial Outcomes & Findings for Use of Infliximab for the Treatment of Pemphigus Vulgaris (NCT NCT00283712)
NCT ID: NCT00283712
Last Updated: 2017-12-06
Results Overview
Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage \<= 25% of the initial starting dose or \<= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline to Week 18
Results posted on
2017-12-06
Participant Flow
Four study centers in the United States enrolled 20 subjects with pemphigus vulgaris (PV) who met entry criteria between August 2005 and December 2010.
Each participant signed an informed consent before undergoing any screening procedures to assess eligibility. Refer to the Eligibility Section for further details.
Participant milestones
| Measure |
Experimental: Infliximab (Remicade, Revellex)
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Intent-to-treat Sample
|
10
|
10
|
|
Overall Study
Safety Sample
|
10
|
10
|
|
Overall Study
Per-Protocol Sample
|
6
|
7
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Experimental: Infliximab (Remicade, Revellex)
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
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Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Use of Infliximab for the Treatment of Pemphigus Vulgaris
Baseline characteristics by cohort
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=10 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Total
n=20 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 15.2 • n=93 Participants
|
51.1 years
STANDARD_DEVIATION 13.9 • n=4 Participants
|
49.2 years
STANDARD_DEVIATION 14.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
PDAI Index Total Score
|
23.0 Total Activity Score
STANDARD_DEVIATION 14.6 • n=93 Participants
|
20.8 Total Activity Score
STANDARD_DEVIATION 10.7 • n=4 Participants
|
21.9 Total Activity Score
STANDARD_DEVIATION 12.4 • n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Mucosal
No oral ulcers
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Mucosal
1 to 5 lesions, small ulcers
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Mucosal
6 to 10 lesions, small ulcers
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Mucosal
>10 lesions or extension erosions
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Cutaneous
No blisters or erosions
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Cutaneous
<20 blisters or <1 to 3% BSA
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Cutaneous
20 to 40 blisters or 3 to 10% BSA
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Cutaneous
>40 blisters or >10% BSA
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Other Organ System
No eye, esophageal, laryngeal involvement
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Pemphigus Vulgaris Disease Activity Score: Other Organ System
Any eye, esophageal, laryngeal involvement
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 18Population: Intent-to-Treat
Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage \<= 25% of the initial starting dose or \<= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=10 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
|
Participant Response to Treatment at Week 18
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 18Population: Safety Population
Grades were based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0. An adverse event (AE) was considered treatment-related if it was classified as unlikely, possibly, probably, or definitely related to study treatment. Participants who experienced at least one treatment-related, grade 3 or higher AE were counted only once. AEs of skin including rash, skin ulceration, and chelitis as defined by the NCI-CTCAE V3.0 System Organ Class of "Skin and Subcutaneous Tissues Disorders" were excluded.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=10 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Treatment-Related Adverse Events >= Grade 3 On or Before Week 18
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Per-protocol
Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage \<= 25% of the initial starting dose or \<=10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=6 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=7 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
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Participant Response to Treatment at Week 18
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Intent-to-Treat
Modified responder status was defined as participants achieving a prednisone dosage \<=25% of the initial starting dose or \<=10 mg/day (whichever is greater) at Week 18 regardless of status on new blister formation during the previous 4 weeks.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=10 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
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Participant Modified Response Status at Week 18
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Subset of Intent-to-Treat Who Experienced Cessation
Time to cessation of new blisters was defined as the time from a participant's first treatment infusion date to the first date where that date and all subsequent dates had no new blisters. Participant diaries were used to assess new blister formation. To achieve cessation, participants had to be free of new blisters at least 3 weeks prior to their last assessment. In order to analyze missing or incomplete data, the data was censored at the date where a participant had no more data or on the date where 50% of the participant's data was missing past that point.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=5 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=3 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
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Participant Time to Cessation of New Blisters
|
133.0 Days
Standard Deviation 31.7
|
98.0 Days
Standard Deviation 49.5
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Subset of Intent-to-Treat Who Experienced Lesion Healing
Time to 80% healing of existing erosions/ulcerations at time of enrollment was assessed using the SAGE II computerized burn-mapping system. The date of 80% healing of existing erosions/ulcerations at time of enrollment was defined as follows: the first date at which the percent of total body surface area (BSA) involved is at least 80% less than the percent of total BSA calculated at the time of enrollment, where the baseline percent of total BSA must be greater than zero percent. If a participant had missing post-baseline assessments, their data was censored at their last non-missing assessment date.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=5 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=4 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
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Time to 80% Lesion Healing
|
77.8 Days
Standard Deviation 74.4
|
58.0 Days
Standard Deviation 36.0
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Subset of Intent-to-Treat Who Experienced Lesion Cessation
Each participant's prednisone dose was summed from the time of enrollment until the date of cessation of new blisters. Actual prednisone use per day was computed as the average over all days in the week.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=5 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=3 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
|
Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters
|
4009.0 mg
Standard Deviation 2351.2
|
6446.7 mg
Standard Deviation 4225.1
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Subset of Intent-to-Treat Who Experienced Erosion Healing
Each participant's prednisone dose was summed from the time of enrollment until the date of 80% healing of existing erosions. Actual prednisone use per day was computed as the average over all days in the week.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=5 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=4 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
|
Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions
|
2921.5 mg
Standard Deviation 2978.2
|
2958.8 mg
Standard Deviation 3223.4
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Intent-to-Treat with available data
The Medical Outcome Study Short Form 36 (MOS SF-36) measures health -related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 18 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=9 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
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|---|---|---|
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Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Mental Component Scale
|
-0.5 units on a scale
Standard Deviation 9.6
|
4.4 units on a scale
Standard Deviation 13.3
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Physical Functioning Scale
|
4.0 units on a scale
Standard Deviation 12.1
|
4.0 units on a scale
Standard Deviation 7.2
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Role Functioning Scale
|
0.3 units on a scale
Standard Deviation 14.2
|
6.3 units on a scale
Standard Deviation 10.7
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Bodily Pain Scale
|
3.7 units on a scale
Standard Deviation 14.8
|
3.2 units on a scale
Standard Deviation 12.1
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
General Health Scale
|
-0.8 units on a scale
Standard Deviation 7.1
|
3.6 units on a scale
Standard Deviation 5.8
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Physical Component Scale
|
2.2 units on a scale
Standard Deviation 8.8
|
3.5 units on a scale
Standard Deviation 7.3
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Vitality Scale
|
-1.6 units on a scale
Standard Deviation 8.1
|
1.7 units on a scale
Standard Deviation 10.1
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Social Functioning Scale
|
0.0 units on a scale
Standard Deviation 11.5
|
3.0 units on a scale
Standard Deviation 13.7
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Role Emotional Scale
|
1.2 units on a scale
Standard Deviation 21.5
|
4.8 units on a scale
Standard Deviation 13.3
|
|
Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18
Mental Health Scale
|
1.4 units on a scale
Standard Deviation 6.5
|
6.6 units on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Intent-to-Treat with available data
The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire with a weighted value to each question. The DLQI score was calculated by summing the score of each question, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the greater quality of life is impaired. Change from baseline values (defined as the visit value - baseline value) were calculated. A negative change indicates better quality of life; a positive change indicates poorer quality of life.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=9 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18
|
-2.0 units on a scale
Standard Deviation 3.1
|
-4.0 units on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Participants in the Intent-to-Treat Population Who Were Responders at Week 18
The primary efficacy endpoint of response to treatment at Week 18 was reassessed at study weeks 22 and 26 for participants who were responders at Week 18. Participants classified as responders had: 1. Achieved a prednisone dosage \<= 25% of the initial starting dose or \<= 10 mg/day (whichever is greater), and 2. had no new blisters within the previous 4 weeks.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=1 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=1 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Participant Duration of Clinical Response
Week 22
|
1 Participants
|
0 Participants
|
|
Participant Duration of Clinical Response
Week 26
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Safety Population
Participants who experienced severe infusion reactions of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=10 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Participants Who Experienced Severe Infusion Reactions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Safety Population
Serious and life-threatening infections of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=10 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Participants Who Experienced Severe Infectious Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Safety Population
Adverse events experienced by participants resulting in study treatment discontinuation and assessed by the investigators as at least possibly related to treatment (i.e., possibly, probably, definitely) were assessed.
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=10 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Adverse Events Resulting in Treatment Discontinuation
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Safety Population
The Pemphigus Vulgaris Disease Activity (PVDA) score was used to grade a participant's disease activity using the SAGE II computerized burn mapping system, which calculated the total body surface area (BSA) involved. Scores were based on the number of new lesions and blisters present, old lesion history and BSA involved. Scores range from 0 to 3 (none to severe disease activity). A new disease activity score of 3 or an old lesion score of 3 indicates active disease. New disease activity scores of 3 for a 1-month duration or an old lesion score of 3 for 2 consecutive months was cause for removal from the study treatment
Outcome measures
| Measure |
Experimental: Infliximab (Remicade, Revellex)
n=10 Participants
Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
Placebo Comparator: Placebo
n=10 Participants
Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Participant Pemphigus Vulgaris Disease Activity Score
New Scores of 3 for a 1- Month Duration
|
0 Participants
|
0 Participants
|
|
Participant Pemphigus Vulgaris Disease Activity Score
Old Lesion Scores of 3 in 2 Consecutive Mos.
|
0 Participants
|
0 Participants
|
Adverse Events
Infliximab
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab
n=10 participants at risk
Subjects randomized to the Infliximab group
|
Placebo
n=10 participants at risk
Subjects randomized to the Placebo group
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Nervous system disorders
Syncope
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
Other adverse events
| Measure |
Infliximab
n=10 participants at risk
Subjects randomized to the Infliximab group
|
Placebo
n=10 participants at risk
Subjects randomized to the Placebo group
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Cardiac disorders
Bradycardia
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Eye disorders
Blepharitis
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 3
All Adverse Events are included due to low sample size (20 participants).
|
|
General disorders
Fatigue
|
30.0%
3/10 • Number of events 3
All Adverse Events are included due to low sample size (20 participants).
|
40.0%
4/10 • Number of events 5
All Adverse Events are included due to low sample size (20 participants).
|
|
General disorders
Feeling hot
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
General disorders
Oedema peripheral
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
General disorders
Pitting oedema
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
General disorders
Pyrexia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Candidiasis
|
10.0%
1/10 • Number of events 3
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Folliculitis
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Influenza
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Rhinitis
|
10.0%
1/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Staphylococcal skin infection
|
10.0%
1/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Tinea pedis
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Injury, poisoning and procedural complications
Back injury
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Injury, poisoning and procedural complications
Excoriation
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Injury, poisoning and procedural complications
Sunburn
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Investigations
Monocyte count increased
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Investigations
Neutrophil count increased
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Investigations
Transaminases increased
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Number of events 5
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 4
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 3
All Adverse Events are included due to low sample size (20 participants).
|
|
Nervous system disorders
Migraine
|
20.0%
2/10 • Number of events 6
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Psychiatric disorders
Hallucination, olfactory
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 3
All Adverse Events are included due to low sample size (20 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
20.0%
2/10 • Number of events 3
All Adverse Events are included due to low sample size (20 participants).
|
20.0%
2/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Vascular disorders
Flushing
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
|
Vascular disorders
Hypertension
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
10.0%
1/10 • Number of events 1
All Adverse Events are included due to low sample size (20 participants).
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 2
All Adverse Events are included due to low sample size (20 participants).
|
0.00%
0/10
All Adverse Events are included due to low sample size (20 participants).
|
Additional Information
Associate Director, Clinical Research Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place