Trial Outcomes & Findings for Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab (NCT NCT01435265)
NCT ID: NCT01435265
Last Updated: 2018-08-29
Results Overview
The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Results posted on
2018-08-29
Participant Flow
Participant milestones
| Measure |
Normal Nurse Education
Subjects receive normal nurse education materials provided by their physician.
|
Additional Nurse Education-
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Normal Nurse Education
Subjects receive normal nurse education materials provided by their physician.
|
Additional Nurse Education-
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab
Baseline characteristics by cohort
| Measure |
Normal Nurse Education
n=3 Participants
Subjects receive normal nurse education materials provided by their physician.
|
Additional Nurse Education-
n=4 Participants
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
55.0 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
51.4 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 monthsPopulation: All participants who completed the study.
The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.
Outcome measures
| Measure |
Normal Nurse Education
n=3 Participants
Subjects receive normal nurse education materials provided by their physician.
|
Additional Nurse Education-
n=4 Participants
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
|
|---|---|---|
|
Change in Psoriasis Area Severity Index (PASI-75)
|
1 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants completing the study.
Investigator's Global Assessment (IGA) is rated on a scale of 0 (clear) to 5 (very severe). The outcome measure to be reported is the number of patients who reached a final IGA of 0 (clear) or 1 (almost clear).
Outcome measures
| Measure |
Normal Nurse Education
n=3 Participants
Subjects receive normal nurse education materials provided by their physician.
|
Additional Nurse Education-
n=3 Participants
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
|
|---|---|---|
|
Investigator's Global Assessment (IGA) of Psoriasis
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: All participants
Adherence measured by average days between doses used, as measured by a Medication Event Monitoring System (MEMS) cap on the disposal container for used syringes.
Outcome measures
| Measure |
Normal Nurse Education
n=3 Participants
Subjects receive normal nurse education materials provided by their physician.
|
Additional Nurse Education-
n=4 Participants
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
|
|---|---|---|
|
Adherence to Adalimumab Treatment
|
19.0 days
Standard Deviation 9.8
|
17.7 days
Standard Deviation 12.1
|
Adverse Events
Normal Nurse Education
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Additional Nurse Education
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Nurse Education
n=3 participants at risk
Subjects receive normal nurse education materials provided by their physician.
|
Additional Nurse Education
n=4 participants at risk
Experimental: Additional Nurse Education- Subjects will receive additional nurse education beyond the normal education materials provided by their physician
|
|---|---|---|
|
General disorders
Abdominal Pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Abscess on R lower leg
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Eye disorders
Blurry/Double vision
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diverticulitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Elevated Blood sugar
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Hepatobiliary disorders
Elevated transaminases
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Fall-Fractured clavicle and great toe
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Hepatobiliary disorders
Fatty Liver
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Fibroid tumor
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Hives
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Hot and Cold Flashes
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Increased forehead wrinkling and perioral pigment changes
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal abscess
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Hepatobiliary disorders
Mild Hepatic Steatosis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Orthostatic Hypertension
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in L lower back radiating to L leg (muscle strain per PCP)
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Possible Keratocanthoma
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Psoriatic arthritis
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Severe Itching
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Sinus Infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Sinus drainage
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Thickening of Cervical Lining
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Vaginal yeast infection
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Worsening of alopecia
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
coryza
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
General disorders
excessive drowsiness/sleepiness
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
recurrent squamous cell carcinoma on R ventral forearm
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Headache
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Abscess on L side
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Psychiatric Hospitalization
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
Other adverse events
Adverse event data not reported
Additional Information
Steven Feldman, MD, PhD
Wake Forest University Health Sciences
Phone: 336-716-7740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place