Trial Outcomes & Findings for Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis (NCT NCT01541917)
NCT ID: NCT01541917
Last Updated: 2017-03-09
Results Overview
Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value ("no pain") and 10 being the highest value ("very much pain").
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
305 participants
Primary outcome timeframe
Baseline, post-treatment, 6-month follow-up, 12-month follow-up
Results posted on
2017-03-09
Participant Flow
For this trial, 305 patients consented (were enrolled) to participate, but 7 of these patients subsequently were found to not fully meet eligibility criteria and 9 of these patients dropped out prior to being randomized. The total randomized sample therefore is 289.
Participant milestones
| Measure |
Web-based Coping Skills Training
Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.
Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.
Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
145
|
|
Overall Study
COMPLETED
|
129
|
136
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
| Measure |
Web-based Coping Skills Training
Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.
Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.
Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
13
|
7
|
Baseline Characteristics
Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis
Baseline characteristics by cohort
| Measure |
Web-based Coping Skills Training
n=144 Participants
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach to review material and help enhance motivation.
|
Online Disease Education Control
n=145 Participants
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual health coach to discuss the participant's efforts at managing his/her disease.
|
Never Randomized
n=16 Participants
This group comprises participants that consented but were never randomized to a condition due to being determined to not meet eligibility criteria or self-withdrawing before randomization.
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Age, Continuous
|
14.65 years
STANDARD_DEVIATION 1.85 • n=5 Participants
|
14.55 years
STANDARD_DEVIATION 1.76 • n=7 Participants
|
15.06 years
STANDARD_DEVIATION 1.69 • n=5 Participants
|
14.59 years
STANDARD_DEVIATION 1.79 • n=4 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
222 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
266 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
256 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-treatment, 6-month follow-up, 12-month follow-upPopulation: All randomized patients were analyzed regardless of whether or not they completed treatment (intent to treat analyses).
Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value ("no pain") and 10 being the highest value ("very much pain").
Outcome measures
| Measure |
Web-based Coping Skills Training
n=144 Participants
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
n=145 Participants
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Change in Pain Intensity
Baseline
|
3.56 Units on a scale
Standard Deviation 2.33
|
3.26 Units on a scale
Standard Deviation 2.38
|
|
Change in Pain Intensity
Post-Treatment
|
3.07 Units on a scale
Standard Deviation 2.47
|
2.90 Units on a scale
Standard Deviation 2.45
|
|
Change in Pain Intensity
6-Month Follow-Up
|
2.87 Units on a scale
Standard Deviation 2.45
|
2.96 Units on a scale
Standard Deviation 2.29
|
|
Change in Pain Intensity
12-Month Follow-Up
|
3.07 Units on a scale
Standard Deviation 2.49
|
2.71 Units on a scale
Standard Deviation 2.43
|
PRIMARY outcome
Timeframe: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-upHealth-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.
Outcome measures
| Measure |
Web-based Coping Skills Training
n=144 Participants
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
n=145 Participants
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Change in PedsQL Rheumatology Health-Related Quality of Life Total Score
Baseline
|
72.56 units on a scale
Standard Deviation 15.52
|
72.44 units on a scale
Standard Deviation 15.81
|
|
Change in PedsQL Rheumatology Health-Related Quality of Life Total Score
Post-Treatment
|
75.68 units on a scale
Standard Deviation 16.68
|
77.78 units on a scale
Standard Deviation 15.02
|
|
Change in PedsQL Rheumatology Health-Related Quality of Life Total Score
6-Month Follow-Up
|
77.32 units on a scale
Standard Deviation 15.64
|
77.12 units on a scale
Standard Deviation 14.41
|
|
Change in PedsQL Rheumatology Health-Related Quality of Life Total Score
12-Month Follow-Up
|
78.26 units on a scale
Standard Deviation 16.23
|
78.04 units on a scale
Standard Deviation 14.33
|
SECONDARY outcome
Timeframe: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-upKnowledge about Juvenile Idiopathic Arthritis was measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire. Responses on this scale are measured on a 0-10 numeric rating scale and averaged together to form a summary score, with 0 being the worst possible score and 10 being the best possible score.
Outcome measures
| Measure |
Web-based Coping Skills Training
n=144 Participants
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
n=145 Participants
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score
Baseline
|
4.78 units on a scale
Standard Deviation 2.35
|
4.57 units on a scale
Standard Deviation 2.20
|
|
Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score
Post-Treatment
|
6.27 units on a scale
Standard Deviation 2.35
|
6.54 units on a scale
Standard Deviation 2.03
|
|
Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score
6-Month Follow-Up
|
6.62 units on a scale
Standard Deviation 2.47
|
6.44 units on a scale
Standard Deviation 2.40
|
|
Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score
12-Month Follow-Up
|
6.45 units on a scale
Standard Deviation 2.62
|
6.65 units on a scale
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-upDisease activity was assessed by the treating physician based on a complete joint count (count of the number of joints that are swollen, painful, tender, or restriction in motion). The lowest (best) value is 0, and the highest (worst) possible value is 300.
Outcome measures
| Measure |
Web-based Coping Skills Training
n=144 Participants
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
n=145 Participants
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Change in Disease Activity
Baseline
|
6.97 joints
Standard Deviation 12.84
|
6.63 joints
Standard Deviation 11.18
|
|
Change in Disease Activity
Post-Treatment
|
5.61 joints
Standard Deviation 9.69
|
6.43 joints
Standard Deviation 10.09
|
|
Change in Disease Activity
6-Month Follow-Up
|
5.45 joints
Standard Deviation 8.29
|
5.35 joints
Standard Deviation 8.14
|
|
Change in Disease Activity
12-Month Follow-Up
|
4.53 joints
Standard Deviation 7.68
|
6.17 joints
Standard Deviation 9.90
|
SECONDARY outcome
Timeframe: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-upConfidence in managing arthritis was measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale. Responses on a 5-point scale ("not at all sure" to "very sure") are averaged together to form a total score, with 0 being the worst possible value and 5 being the best possible value.
Outcome measures
| Measure |
Web-based Coping Skills Training
n=144 Participants
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
n=145 Participants
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Change in Children's Arthritis Self-Efficacy (CASE) Scores
Baseline
|
3.31 units on a scale
Standard Deviation .96
|
3.32 units on a scale
Standard Deviation 1.05
|
|
Change in Children's Arthritis Self-Efficacy (CASE) Scores
Post-Treatment
|
3.80 units on a scale
Standard Deviation .88
|
3.67 units on a scale
Standard Deviation .99
|
|
Change in Children's Arthritis Self-Efficacy (CASE) Scores
6-Month Follow-Up
|
3.81 units on a scale
Standard Deviation .94
|
3.73 units on a scale
Standard Deviation 1.0
|
|
Change in Children's Arthritis Self-Efficacy (CASE) Scores
12-Month Follow-Up
|
3.75 units on a scale
Standard Deviation .96
|
3.81 units on a scale
Standard Deviation .98
|
SECONDARY outcome
Timeframe: Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-upScores on the Approach Coping sub-scale of the Pain Coping Questionnaire were used to measure approach coping, which is a type of coping considered to be adaptive and helpful for pain. Responses to items on this subscale are on a 5-point scale ("never use" to "very often use") and are averaged together for the subscale score, such that scores range from a worst possible value of 1 to a best possible value of 5.
Outcome measures
| Measure |
Web-based Coping Skills Training
n=144 Participants
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
n=145 Participants
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Change in Approach Coping
Baseline
|
2.63 units on a scale
Standard Deviation .75
|
2.57 units on a scale
Standard Deviation .73
|
|
Change in Approach Coping
Post-Treatment
|
2.84 units on a scale
Standard Deviation .87
|
2.67 units on a scale
Standard Deviation .88
|
|
Change in Approach Coping
6-Month Follow-Up
|
2.76 units on a scale
Standard Deviation .90
|
2.55 units on a scale
Standard Deviation .87
|
|
Change in Approach Coping
12-Month Follow-Up
|
2.71 units on a scale
Standard Deviation 1.03
|
2.55 units on a scale
Standard Deviation .88
|
Adverse Events
Web-based Coping Skills Training
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Online Disease Education Control
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Web-based Coping Skills Training
n=144 participants at risk
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
n=145 participants at risk
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
0.69%
1/144 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
2.1%
3/145 • Number of events 4 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Musculoskeletal and connective tissue disorders
Arthritis flare
|
0.69%
1/144 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
0.00%
0/145 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Infections and infestations
Hospitalized for macrophage activation syndrome
|
0.00%
0/144 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
0.69%
1/145 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Infections and infestations
Hospitalized for appendicitis
|
0.00%
0/144 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
0.69%
1/145 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Immune system disorders
Hospitalized for management of Crohn's disease flare
|
0.69%
1/144 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
0.00%
0/145 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Psychiatric disorders
Hospitalized for suicidal thoughts
|
0.69%
1/144 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
0.00%
0/145 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
Other adverse events
| Measure |
Web-based Coping Skills Training
n=144 participants at risk
This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
|
Online Disease Education Control
n=145 participants at risk
The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse "health coach" to discuss the participant's efforts at managing his/her disease.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin system findings (psoriasis, rash)
|
3.5%
5/144 • Number of events 6 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
2.1%
3/145 • Number of events 4 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Injury, poisoning and procedural complications
Injury (e.g., sprain, fracture)
|
1.4%
2/144 • Number of events 2 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
2.1%
3/145 • Number of events 3 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.69%
1/144 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
4.8%
7/145 • Number of events 8 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Infections and infestations
Infection
|
4.9%
7/144 • Number of events 7 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
7.6%
11/145 • Number of events 11 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Blood and lymphatic system disorders
Blood disorder/problems
|
2.1%
3/144 • Number of events 3 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
1.4%
2/145 • Number of events 2 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Nervous system disorders
Dizziness and/or fatigue
|
1.4%
2/144 • Number of events 2 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
1.4%
2/145 • Number of events 2 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Immune system disorders
Arthritis flare
|
9.0%
13/144 • Number of events 18 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
2.8%
4/145 • Number of events 4 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Psychiatric disorders
Depression
|
2.1%
3/144 • Number of events 3 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
0.69%
1/145 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
|
Psychiatric disorders
Suicidal thoughts
|
1.4%
2/144 • Number of events 2 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
0.69%
1/145 • Number of events 1 • Adverse events were monitored throughout participants' active participation in the trial, through 12 month follow-up.
Information on adverse events were collected at each study visit (post-treatment, 6-month follow-up, 12-month follow-up) using a standardized electronic form.
|
Additional Information
Mark Connelly, PhD (Principal Investigator)
Children's Mercy Hospital
Phone: 816-234-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place