Trial Outcomes & Findings for Study of Anti-Malarials in Incomplete Lupus Erythematosus (NCT NCT03030118)
NCT ID: NCT03030118
Last Updated: 2025-09-16
Results Overview
The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus Minimum value = 0 Maximum value = 17 A score of 4 or greater satisfies classification for systemic lupus erythematosus.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
Measured every 12 weeks for 96 weeks.
Results posted on
2025-09-16
Participant Flow
Participant milestones
| Measure |
Hydroxychloroquine
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
94
|
|
Overall Study
COMPLETED
|
43
|
47
|
|
Overall Study
NOT COMPLETED
|
50
|
47
|
Reasons for withdrawal
| Measure |
Hydroxychloroquine
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Overall Study
Achieved SLE Diagnosis
|
11
|
10
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Pregnancy
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Concomitant Medications
|
1
|
1
|
|
Overall Study
Achieved SLE and Concomitant Meds
|
1
|
0
|
|
Overall Study
Other
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
26
|
21
|
|
Overall Study
Protocol Violation
|
1
|
6
|
Baseline Characteristics
Study of Anti-Malarials in Incomplete Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Hydroxychloroquine
n=92 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 8.58 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=5 Participants
|
88 participants
n=7 Participants
|
180 participants
n=5 Participants
|
|
Systemic Lupus International Cooperating Clinics (SLICC) score baseline
2 criteria
|
62 Number of criteria
n=5 Participants
|
56 Number of criteria
n=7 Participants
|
118 Number of criteria
n=5 Participants
|
|
Systemic Lupus International Cooperating Clinics (SLICC) score baseline
3 criteria
|
30 Number of criteria
n=5 Participants
|
32 Number of criteria
n=7 Participants
|
62 Number of criteria
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured every 12 weeks for 96 weeks.Population: Analysis at each timepoint includes only the number patients who were still active in the study.
The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus Minimum value = 0 Maximum value = 17 A score of 4 or greater satisfies classification for systemic lupus erythematosus.
Outcome measures
| Measure |
Hydroxychloroquine
n=92 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
SLICC Score
SLICC score of 2 : baseline
|
62 participants
|
56 participants
|
|
SLICC Score
SLICC score of 2 : 12 weeks
|
46 participants
|
41 participants
|
|
SLICC Score
SLICC score of 2 : 24 weeks
|
35 participants
|
40 participants
|
|
SLICC Score
SLICC score of 2 : 36 weeks
|
31 participants
|
34 participants
|
|
SLICC Score
SLICC score of 2 : 48 weeks
|
30 participants
|
29 participants
|
|
SLICC Score
SLICC score of 2 : 60 weeks
|
23 participants
|
26 participants
|
|
SLICC Score
SLICC score of 2 : 72 weeks
|
21 participants
|
24 participants
|
|
SLICC Score
SLICC score of 2 : 84 weeks
|
21 participants
|
22 participants
|
|
SLICC Score
SLICC score of 2 : 96 weeks
|
21 participants
|
22 participants
|
|
SLICC Score
SLICC score of 3 : baseline
|
30 participants
|
32 participants
|
|
SLICC Score
SLICC score of 3 : 12 weeks
|
33 participants
|
31 participants
|
|
SLICC Score
SLICC score of 3 : 24 weeks
|
32 participants
|
27 participants
|
|
SLICC Score
SLICC score of 3 : 36 weeks
|
29 participants
|
25 participants
|
|
SLICC Score
SLICC score of 3 : 48 weeks
|
24 participants
|
25 participants
|
|
SLICC Score
SLICC score of 3 : 60 weeks
|
28 participants
|
23 participants
|
|
SLICC Score
SLICC score of 3 : 72 weeks
|
26 participants
|
21 participants
|
|
SLICC Score
SLICC score of 3 : 84 weeks
|
22 participants
|
25 participants
|
|
SLICC Score
SLICC score of 3 : 96 weeks
|
24 participants
|
26 participants
|
|
SLICC Score
SLICC score of 4 or more : baseline
|
0 participants
|
0 participants
|
|
SLICC Score
SLICC score of 4 or more : 12 weeks
|
0 participants
|
2 participants
|
|
SLICC Score
SLICC score of 4 or more : 24 weeks
|
3 participants
|
4 participants
|
|
SLICC Score
SLICC score of 4 or more : 36 weeks
|
1 participants
|
3 participants
|
|
SLICC Score
SLICC score of 4 or more : 48 weeks
|
2 participants
|
1 participants
|
|
SLICC Score
SLICC score of 4 or more : 60 weeks
|
3 participants
|
0 participants
|
|
SLICC Score
SLICC score of 4 or more : 72 weeks
|
2 participants
|
0 participants
|
|
SLICC Score
SLICC score of 4 or more : 84 weeks
|
2 participants
|
0 participants
|
|
SLICC Score
SLICC score of 4 or more : 96 weeks
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Measured up to 96 weeks.Population: Analyzed via survival method. TIme to progression, Kaplan Meier.
The number of subjects who progressed from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria.
Outcome measures
| Measure |
Hydroxychloroquine
n=92 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Number of Subjects With Disease Progression
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Measured every 12 weeks for 96 weeks.Population: Count includes number of participants active at each visit. Groups: Score 0-1, Score 2-3, Score 4-8.
Disease activity measured by the SLE Disease Activity Index Minimum score = 0 Maximum score = 105 Higher scores indicate greater activity of lupus disease
Outcome measures
| Measure |
Hydroxychloroquine
n=92 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
week 12 Score 4-8
|
8 Participants
|
16 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 24 Score 4-8
|
10 Participants
|
11 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 36 Score 4-8
|
11 Participants
|
12 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 48 Score 4-8
|
9 Participants
|
7 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 60 Score 4-8
|
10 Participants
|
8 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 72 Score 4-8
|
8 Participants
|
5 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 84 Score 4-8
|
5 Participants
|
4 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Baseline Score 0-1
|
43 Participants
|
45 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 12 Score 0-1
|
44 Participants
|
37 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 24 Score 0-1
|
36 Participants
|
45 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 36 Score 0-1
|
36 Participants
|
38 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 48 Score 0-1
|
35 Participants
|
36 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 60 Score 0-1
|
35 Participants
|
32 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 72 Score 0-1
|
28 Participants
|
34 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 84 Score 0-1
|
33 Participants
|
35 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 96 Score 0-1
|
29 Participants
|
36 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Baseline Score 2-3
|
28 Participants
|
23 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 12 Score 2-3
|
27 Participants
|
20 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 24 Score 2-3
|
24 Participants
|
17 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 36 Score 2-3
|
16 Participants
|
13 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 48 Score 2-3
|
13 Participants
|
12 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 60 score 2-3
|
11 Participants
|
9 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 72 Score 2-3
|
13 Participants
|
6 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 84 Score 2-3
|
9 Participants
|
8 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 96 Sc ore 2-3
|
10 Participants
|
9 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Baseline Score 4-8
|
21 Participants
|
20 Participants
|
|
Number of Subjects Meeting Disease Activity Scores Defined Below
Week 96 Score 4-8
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Measured every 12 weeks for 96 weeksPopulation: Data are shown for number of active patients at each timepoint. CLASI activity score is measured as 0,1,2 or 3 and higher. At some timepoints, Data are Missing.
Disease activity measured by the Cutaneous Lupus Erythematosus Disease Activity Index Minimum score = 0 Maximum score = 70 Higher scores indicate greater cutaneous lupus activity
Outcome measures
| Measure |
Hydroxychloroquine
n=92 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Count of Participants With Defined Disease Activity
Baseline · Missing data
|
0 Participants
|
0 Participants
|
|
Count of Participants With Defined Disease Activity
Baseline · Score 0
|
67 Participants
|
66 Participants
|
|
Count of Participants With Defined Disease Activity
Baseline · Score 1
|
9 Participants
|
10 Participants
|
|
Count of Participants With Defined Disease Activity
Baseline · Score 2
|
8 Participants
|
9 Participants
|
|
Count of Participants With Defined Disease Activity
Baseline · Score 3 or higher
|
8 Participants
|
3 Participants
|
|
Count of Participants With Defined Disease Activity
Week 12 · Missing data
|
4 Participants
|
6 Participants
|
|
Count of Participants With Defined Disease Activity
Week 12 · Score 0
|
59 Participants
|
51 Participants
|
|
Count of Participants With Defined Disease Activity
Week 12 · Score 1
|
8 Participants
|
10 Participants
|
|
Count of Participants With Defined Disease Activity
Week 12 · Score 2
|
3 Participants
|
7 Participants
|
|
Count of Participants With Defined Disease Activity
Week 12 · Score 3 or higher
|
8 Participants
|
5 Participants
|
|
Count of Participants With Defined Disease Activity
Week 24 · Missing data
|
5 Participants
|
3 Participants
|
|
Count of Participants With Defined Disease Activity
Week 24 · Score 0
|
52 Participants
|
61 Participants
|
|
Count of Participants With Defined Disease Activity
Week 24 · Score 1
|
9 Participants
|
3 Participants
|
|
Count of Participants With Defined Disease Activity
Week 24 · Score 2
|
3 Participants
|
5 Participants
|
|
Count of Participants With Defined Disease Activity
Week 24 · Score 3 or higher
|
5 Participants
|
4 Participants
|
|
Count of Participants With Defined Disease Activity
Week 36 · Missing data
|
5 Participants
|
4 Participants
|
|
Count of Participants With Defined Disease Activity
Week 36 · Score 0
|
50 Participants
|
49 Participants
|
|
Count of Participants With Defined Disease Activity
Week 36 · Score 1
|
5 Participants
|
4 Participants
|
|
Count of Participants With Defined Disease Activity
Week 36 · Score 2
|
3 Participants
|
5 Participants
|
|
Count of Participants With Defined Disease Activity
Week 36 · Score 3 or higher
|
5 Participants
|
5 Participants
|
|
Count of Participants With Defined Disease Activity
Week 48 · Missing data
|
5 Participants
|
3 Participants
|
|
Count of Participants With Defined Disease Activity
Week 48 · Score 0
|
45 Participants
|
44 Participants
|
|
Count of Participants With Defined Disease Activity
Week 48 · Score 1
|
5 Participants
|
4 Participants
|
|
Count of Participants With Defined Disease Activity
Week 48 · Score 2
|
2 Participants
|
2 Participants
|
|
Count of Participants With Defined Disease Activity
Week 48 · Score 3 or higher
|
5 Participants
|
5 Participants
|
|
Count of Participants With Defined Disease Activity
Week 60 · Missing data
|
3 Participants
|
5 Participants
|
|
Count of Participants With Defined Disease Activity
Week 60 · Score 0
|
42 Participants
|
38 Participants
|
|
Count of Participants With Defined Disease Activity
Week 60 · Score 1
|
7 Participants
|
4 Participants
|
|
Count of Participants With Defined Disease Activity
Week 60 · Score 2
|
3 Participants
|
3 Participants
|
|
Count of Participants With Defined Disease Activity
Week 60 · Score 3 or higher
|
4 Participants
|
4 Participants
|
|
Count of Participants With Defined Disease Activity
Week 72 · Missing data
|
2 Participants
|
5 Participants
|
|
Count of Participants With Defined Disease Activity
Week 72 · Score 0
|
42 Participants
|
40 Participants
|
|
Count of Participants With Defined Disease Activity
Week 72 · Score 1
|
3 Participants
|
1 Participants
|
|
Count of Participants With Defined Disease Activity
Week 72 · Score 2
|
3 Participants
|
2 Participants
|
|
Count of Participants With Defined Disease Activity
Week 72 · Score 3 or higher
|
1 Participants
|
2 Participants
|
|
Count of Participants With Defined Disease Activity
Week 84 · Missing data
|
4 Participants
|
3 Participants
|
|
Count of Participants With Defined Disease Activity
Week 84 · Score 0
|
39 Participants
|
40 Participants
|
|
Count of Participants With Defined Disease Activity
Week 84 · Score 1
|
2 Participants
|
1 Participants
|
|
Count of Participants With Defined Disease Activity
Week 84 · Score 2
|
5 Participants
|
4 Participants
|
|
Count of Participants With Defined Disease Activity
Week 84 · Score 3 or higher
|
0 Participants
|
2 Participants
|
|
Count of Participants With Defined Disease Activity
Week 96 · Missing data
|
1 Participants
|
0 Participants
|
|
Count of Participants With Defined Disease Activity
Week 96 · Score 0
|
36 Participants
|
43 Participants
|
|
Count of Participants With Defined Disease Activity
Week 96 · Score 1
|
5 Participants
|
3 Participants
|
|
Count of Participants With Defined Disease Activity
Week 96 · Score 2
|
4 Participants
|
2 Participants
|
|
Count of Participants With Defined Disease Activity
Week 96 · Score 3 or higher
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured every 12 weeks for 96 weeksPopulation: Only patients active at each visit are measured.
The PROMIS 29 Adult Profile: Physical Function T Scores The T-score has a mean of 50 and a standard deviation of 10 within the reference (healthy) population. Higher score indicates better physical function
Outcome measures
| Measure |
Hydroxychloroquine
n=92 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Patient Reported Outcome Physical Function
Baseline
|
48.5 T score
Standard Deviation 8.26
|
48.9 T score
Standard Deviation 7.87
|
|
Patient Reported Outcome Physical Function
12 weeks
|
49.6 T score
Standard Deviation 7.71
|
49.7 T score
Standard Deviation 7.84
|
|
Patient Reported Outcome Physical Function
24 weeks
|
49.5 T score
Standard Deviation 7.73
|
49.4 T score
Standard Deviation 8.42
|
|
Patient Reported Outcome Physical Function
36 weeks
|
48.8 T score
Standard Deviation 8.12
|
49.2 T score
Standard Deviation 8.6
|
|
Patient Reported Outcome Physical Function
48 weeks
|
48.6 T score
Standard Deviation 8.3
|
49.9 T score
Standard Deviation 7.89
|
|
Patient Reported Outcome Physical Function
60 weeks
|
49.6 T score
Standard Deviation 8.06
|
49.4 T score
Standard Deviation 7.92
|
|
Patient Reported Outcome Physical Function
72 weeks
|
49.3 T score
Standard Deviation 8.28
|
50.1 T score
Standard Deviation 8.24
|
|
Patient Reported Outcome Physical Function
84 weeks
|
49.7 T score
Standard Deviation 7.84
|
48.7 T score
Standard Deviation 8.55
|
|
Patient Reported Outcome Physical Function
96 weeks
|
48.5 T score
Standard Deviation 8.17
|
50.1 T score
Standard Deviation 7.93
|
SECONDARY outcome
Timeframe: Measured every 12 weeks for up to 96 weeksPopulation: Only active patients are recorded at each visit. Values represent Fatigue T-scores.
Selected Patient-reported outcomes measurement information system (PROMIS) fatigue items T Scores are reported. The T-score has a mean of 50 and a standard deviation of 10 within the reference (healthy) population. Higher scores indicate more fatigue
Outcome measures
| Measure |
Hydroxychloroquine
n=92 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Patient Reported Outcomes Fatigue
Baseline
|
54.7 T score
Standard Deviation 10.8
|
55.0 T score
Standard Deviation 10.87
|
|
Patient Reported Outcomes Fatigue
12 weeks
|
53.0 T score
Standard Deviation 10.6
|
53.1 T score
Standard Deviation 11.2
|
|
Patient Reported Outcomes Fatigue
24 weeks
|
52.2 T score
Standard Deviation 10.2
|
53.2 T score
Standard Deviation 12.0
|
|
Patient Reported Outcomes Fatigue
36 weeks
|
52.3 T score
Standard Deviation 10.5
|
51.8 T score
Standard Deviation 11.4
|
|
Patient Reported Outcomes Fatigue
48 weeks
|
51.5 T score
Standard Deviation 10.6
|
51.4 T score
Standard Deviation 11.3
|
|
Patient Reported Outcomes Fatigue
60 weeks
|
51.1 T score
Standard Deviation 11.0
|
49.1 T score
Standard Deviation 9.8
|
|
Patient Reported Outcomes Fatigue
72 weeks
|
50.9 T score
Standard Deviation 11.2
|
50.3 T score
Standard Deviation 11.2
|
|
Patient Reported Outcomes Fatigue
84 weeks
|
51.7 T score
Standard Deviation 8.6
|
51.1 T score
Standard Deviation 10.5
|
|
Patient Reported Outcomes Fatigue
96 weeks
|
51.9 T score
Standard Deviation 11.3
|
50.7 T score
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Measured every 12 weeks for up to 96 weeksPopulation: Number of active patients at each time point are measured.
Physician Global Visual Analogue Scale Minimum score = 0 Maximum score = 1.0 Higher scores indicate worse status
Outcome measures
| Measure |
Hydroxychloroquine
n=92 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Physician Global Asssessment
Week 96 · Missing data
|
2 Participants
|
1 Participants
|
|
Physician Global Asssessment
Baseline · Missing data
|
1 Participants
|
1 Participants
|
|
Physician Global Asssessment
Baseline · Score 0
|
39 Participants
|
40 Participants
|
|
Physician Global Asssessment
Baseline · Score 0.25
|
35 Participants
|
31 Participants
|
|
Physician Global Asssessment
Baseline · Score 0.50
|
14 Participants
|
14 Participants
|
|
Physician Global Asssessment
Baseline · Score 0.75 or higher
|
3 Participants
|
2 Participants
|
|
Physician Global Asssessment
Week 12 · Missing data
|
4 Participants
|
7 Participants
|
|
Physician Global Asssessment
Week 12 · Score 0
|
46 Participants
|
39 Participants
|
|
Physician Global Asssessment
Week 12 · Score 0.25
|
23 Participants
|
23 Participants
|
|
Physician Global Asssessment
Week 12 · Score 0.50
|
4 Participants
|
8 Participants
|
|
Physician Global Asssessment
Week 12 · Score 0.75 or higher
|
5 Participants
|
2 Participants
|
|
Physician Global Asssessment
Week 24 · Missing data
|
4 Participants
|
4 Participants
|
|
Physician Global Asssessment
Week 24 · Score 0
|
35 Participants
|
43 Participants
|
|
Physician Global Asssessment
Week 24 · Score 0.25
|
24 Participants
|
19 Participants
|
|
Physician Global Asssessment
Week 24 · Score 0.50
|
9 Participants
|
7 Participants
|
|
Physician Global Asssessment
Week 24 · Score 0.75 or higher
|
2 Participants
|
3 Participants
|
|
Physician Global Asssessment
Week 36 · Missing data
|
6 Participants
|
6 Participants
|
|
Physician Global Asssessment
Week 36 · Score 0
|
41 Participants
|
34 Participants
|
|
Physician Global Asssessment
Week 36 · Score 0.25
|
15 Participants
|
16 Participants
|
|
Physician Global Asssessment
Week 36 · Score 0.50
|
5 Participants
|
7 Participants
|
|
Physician Global Asssessment
Week 36 · Score 0.75 or higher
|
1 Participants
|
4 Participants
|
|
Physician Global Asssessment
Week 48 · Missing data
|
5 Participants
|
3 Participants
|
|
Physician Global Asssessment
Week 48 · Score 0
|
39 Participants
|
37 Participants
|
|
Physician Global Asssessment
Week 48 · Score 0.25
|
14 Participants
|
11 Participants
|
|
Physician Global Asssessment
Week 48 · Score 0.50
|
4 Participants
|
5 Participants
|
|
Physician Global Asssessment
Week 48 · Score 0.75 or higher
|
0 Participants
|
2 Participants
|
|
Physician Global Asssessment
Week 60 · Missing data
|
4 Participants
|
6 Participants
|
|
Physician Global Asssessment
Week 60 · Score 0
|
33 Participants
|
33 Participants
|
|
Physician Global Asssessment
Week 60 · Score 0.25
|
13 Participants
|
6 Participants
|
|
Physician Global Asssessment
Week 60 · Score 0.50
|
7 Participants
|
7 Participants
|
|
Physician Global Asssessment
Week 60 · Score 0.75 or higher
|
2 Participants
|
2 Participants
|
|
Physician Global Asssessment
Week 72 · Missing data
|
4 Participants
|
5 Participants
|
|
Physician Global Asssessment
Week 72 · Score 0
|
25 Participants
|
29 Participants
|
|
Physician Global Asssessment
Week 72 · Score 0.25
|
19 Participants
|
15 Participants
|
|
Physician Global Asssessment
Week 72 · Score 0.50
|
3 Participants
|
1 Participants
|
|
Physician Global Asssessment
Week 72 · Score 0.75 or higher
|
0 Participants
|
0 Participants
|
|
Physician Global Asssessment
Week 84 · Missing data
|
4 Participants
|
3 Participants
|
|
Physician Global Asssessment
Week 84 · Score 0
|
35 Participants
|
37 Participants
|
|
Physician Global Asssessment
Week 84 · Score 0.25
|
8 Participants
|
9 Participants
|
|
Physician Global Asssessment
Week 84 · Score 0.50
|
3 Participants
|
1 Participants
|
|
Physician Global Asssessment
Week 84 · Score 0.75 or higher
|
0 Participants
|
0 Participants
|
|
Physician Global Asssessment
Week 96 · Score 0
|
31 Participants
|
38 Participants
|
|
Physician Global Asssessment
Week 96 · Score 0.25
|
11 Participants
|
6 Participants
|
|
Physician Global Asssessment
Week 96 · Score 0.50
|
2 Participants
|
3 Participants
|
|
Physician Global Asssessment
Week 96 · Score 0.75 or higher
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured at baseline and final visit up to 96 weeks.Population: Only patients who completed or who had a defined final visit are included. Samples were measured at baseline and last visit.
Fluorescence intensity of Autoantibodies will be measured using a slide array. Minimum score is 0.1 Maximum score \>100 A higher score indicates higher level of the autoantibody being measured.
Outcome measures
| Measure |
Hydroxychloroquine
n=74 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=78 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline IFN-alpha
|
1813 Mean Fluorescence Intensity
Standard Deviation 1619
|
2049 Mean Fluorescence Intensity
Standard Deviation 1960
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline IFN-gamma
|
9092 Mean Fluorescence Intensity
Standard Deviation 6184
|
9373 Mean Fluorescence Intensity
Standard Deviation 7330
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline CENP-A
|
1319 Mean Fluorescence Intensity
Standard Deviation 869
|
1243 Mean Fluorescence Intensity
Standard Deviation 1222
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline CENP-B
|
5461 Mean Fluorescence Intensity
Standard Deviation 2703
|
5454 Mean Fluorescence Intensity
Standard Deviation 3029
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline dsDNA
|
2838 Mean Fluorescence Intensity
Standard Deviation 2766
|
2582 Mean Fluorescence Intensity
Standard Deviation 4289
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Genomic DNA
|
4484 Mean Fluorescence Intensity
Standard Deviation 7821
|
3362 Mean Fluorescence Intensity
Standard Deviation 2458
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline HIstone
|
2349 Mean Fluorescence Intensity
Standard Deviation 2118
|
2145 Mean Fluorescence Intensity
Standard Deviation 1703
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline IL-17A
|
9991 Mean Fluorescence Intensity
Standard Deviation 6075
|
9953 Mean Fluorescence Intensity
Standard Deviation 5816
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline KU. (P70/P80)
|
3933 Mean Fluorescence Intensity
Standard Deviation 5283
|
3967 Mean Fluorescence Intensity
Standard Deviation 5697
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline La/SSB
|
4682 Mean Fluorescence Intensity
Standard Deviation 9508
|
4703 Mean Fluorescence Intensity
Standard Deviation 10076
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Laminin
|
16234 Mean Fluorescence Intensity
Standard Deviation 17545
|
15573 Mean Fluorescence Intensity
Standard Deviation 16455
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Liver Baseline Cytosol '
|
3563 Mean Fluorescence Intensity
Standard Deviation 3632
|
3267 Mean Fluorescence Intensity
Standard Deviation 3074
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
baseline LKM 1
|
3067 Mean Fluorescence Intensity
Standard Deviation 1321
|
2903 Mean Fluorescence Intensity
Standard Deviation 1151
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline MDA5
|
3725 Mean Fluorescence Intensity
Standard Deviation 4064
|
3483 Mean Fluorescence Intensity
Standard Deviation 3476
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Mi-2
|
1140 Mean Fluorescence Intensity
Standard Deviation 760
|
1067 Mean Fluorescence Intensity
Standard Deviation 679
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline NRP1
|
23735 Mean Fluorescence Intensity
Standard Deviation 20781
|
24296 Mean Fluorescence Intensity
Standard Deviation 21025
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Nucleolin
|
3108 Mean Fluorescence Intensity
Standard Deviation 2148
|
2748 Mean Fluorescence Intensity
Standard Deviation 1576
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Nucleosome
|
3017 Mean Fluorescence Intensity
Standard Deviation 1661
|
2800 Mean Fluorescence Intensity
Standard Deviation 1255
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline NXP2
|
3765 Mean Fluorescence Intensity
Standard Deviation 2275
|
3584 Mean Fluorescence Intensity
Standard Deviation 2228
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline PL-7
|
2681 Mean Fluorescence Intensity
Standard Deviation 1335
|
2352 Mean Fluorescence Intensity
Standard Deviation 973
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline PL-12
|
6040 Mean Fluorescence Intensity
Standard Deviation 2533
|
5672 Mean Fluorescence Intensity
Standard Deviation 1905
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline PM/SCL-100
|
2967 Mean Fluorescence Intensity
Standard Deviation 2631
|
2650 Mean Fluorescence Intensity
Standard Deviation 1919
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Ro/SSA 60 KDA
|
1800 Mean Fluorescence Intensity
Standard Deviation 4705
|
1879 Mean Fluorescence Intensity
Standard Deviation 5617
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Scl-70
|
1596 Mean Fluorescence Intensity
Standard Deviation 1499
|
1569 Mean Fluorescence Intensity
Standard Deviation 1231
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Sm
|
1347 Mean Fluorescence Intensity
Standard Deviation 1677
|
1135 Mean Fluorescence Intensity
Standard Deviation 1087
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline thyroglobulin
|
4211 Mean Fluorescence Intensity
Standard Deviation 7237
|
2933 Mean Fluorescence Intensity
Standard Deviation 4782
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline TPO
|
7986 Mean Fluorescence Intensity
Standard Deviation 9281
|
6769 Mean Fluorescence Intensity
Standard Deviation 7279
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline tTG
|
6966 Mean Fluorescence Intensity
Standard Deviation 4280
|
6381 Mean Fluorescence Intensity
Standard Deviation 3164
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline U1-snRNPA
|
2372 Mean Fluorescence Intensity
Standard Deviation 2869
|
2184 Mean Fluorescence Intensity
Standard Deviation 2701
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline U1-snRNP C
|
657 Mean Fluorescence Intensity
Standard Deviation 819
|
602 Mean Fluorescence Intensity
Standard Deviation 821
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline U1-snRNP B/B
|
260 Mean Fluorescence Intensity
Standard Deviation 110
|
252 Mean Fluorescence Intensity
Standard Deviation 94
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Baseline Vimentin
|
3160 Mean Fluorescence Intensity
Standard Deviation 1670
|
3006 Mean Fluorescence Intensity
Standard Deviation 1140
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final CENP-A
|
1243 Mean Fluorescence Intensity
Standard Deviation 1222
|
1889 Mean Fluorescence Intensity
Standard Deviation 7462
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final CENP-B
|
5454 Mean Fluorescence Intensity
Standard Deviation 3029
|
6367 Mean Fluorescence Intensity
Standard Deviation 8328
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final dsDNA
|
2582 Mean Fluorescence Intensity
Standard Deviation 4289
|
2496 Mean Fluorescence Intensity
Standard Deviation 2472
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Genomic DNA
|
3362 Mean Fluorescence Intensity
Standard Deviation 2458
|
3595 Mean Fluorescence Intensity
Standard Deviation 3971
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Histone
|
2145 Mean Fluorescence Intensity
Standard Deviation 1703
|
2304 Mean Fluorescence Intensity
Standard Deviation 2636
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final IFN-alpha
|
2049 Mean Fluorescence Intensity
Standard Deviation 1960
|
2150 Mean Fluorescence Intensity
Standard Deviation 2096
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final IFN-gamma
|
9373 Mean Fluorescence Intensity
Standard Deviation 7330
|
10235 Mean Fluorescence Intensity
Standard Deviation 6071
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final IL-17A
|
9953 Mean Fluorescence Intensity
Standard Deviation 5816
|
11656 Mean Fluorescence Intensity
Standard Deviation 6798
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Ku P70/P80
|
3967 Mean Fluorescence Intensity
Standard Deviation 5697
|
4209 Mean Fluorescence Intensity
Standard Deviation 4440
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final La/SS-B
|
4703 Mean Fluorescence Intensity
Standard Deviation 10076
|
2881 Mean Fluorescence Intensity
Standard Deviation 1677
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Laminin
|
15573 Mean Fluorescence Intensity
Standard Deviation 16455
|
18192 Mean Fluorescence Intensity
Standard Deviation 19262
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Liver Cytosol 1
|
3267 Mean Fluorescence Intensity
Standard Deviation 3074
|
3538 Mean Fluorescence Intensity
Standard Deviation 3506
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final LKM 1
|
2903 Mean Fluorescence Intensity
Standard Deviation 1151
|
3323 Mean Fluorescence Intensity
Standard Deviation 1549
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final MDA5
|
3483 Mean Fluorescence Intensity
Standard Deviation 3476
|
4262 Mean Fluorescence Intensity
Standard Deviation 2636
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Mi-2
|
1067 Mean Fluorescence Intensity
Standard Deviation 679
|
1299 Mean Fluorescence Intensity
Standard Deviation 736
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Nrp1
|
24296 Mean Fluorescence Intensity
Standard Deviation 21025
|
25597 Mean Fluorescence Intensity
Standard Deviation 22237
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Nucleolin
|
2748 Mean Fluorescence Intensity
Standard Deviation 1576
|
3721 Mean Fluorescence Intensity
Standard Deviation 2291
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Nucleosome
|
2800 Mean Fluorescence Intensity
Standard Deviation 1255
|
3292 Mean Fluorescence Intensity
Standard Deviation 1595
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final NXP2
|
3584 Mean Fluorescence Intensity
Standard Deviation 2228
|
4598 Mean Fluorescence Intensity
Standard Deviation 2627
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final PL-7
|
2352 Mean Fluorescence Intensity
Standard Deviation 973
|
2861 Mean Fluorescence Intensity
Standard Deviation 1790
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final PL-12
|
5672 Mean Fluorescence Intensity
Standard Deviation 1905
|
6673 Mean Fluorescence Intensity
Standard Deviation 2873
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final PM/Scl 100
|
2650 Mean Fluorescence Intensity
Standard Deviation 1919
|
2982 Mean Fluorescence Intensity
Standard Deviation 1768
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Ro/SS-A 60 Kda
|
1879 Mean Fluorescence Intensity
Standard Deviation 5617
|
1421 Mean Fluorescence Intensity
Standard Deviation 908
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Scl-70
|
1569 Mean Fluorescence Intensity
Standard Deviation 1231
|
2009 Mean Fluorescence Intensity
Standard Deviation 4108
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Sm
|
1135 Mean Fluorescence Intensity
Standard Deviation 1087
|
1858 Mean Fluorescence Intensity
Standard Deviation 5755
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Thyroglobulin
|
2933 Mean Fluorescence Intensity
Standard Deviation 4782
|
3651 Mean Fluorescence Intensity
Standard Deviation 6602
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final TPO
|
6769 Mean Fluorescence Intensity
Standard Deviation 7279
|
6873 Mean Fluorescence Intensity
Standard Deviation 4793
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final tTg
|
6381 Mean Fluorescence Intensity
Standard Deviation 3164
|
6356 Mean Fluorescence Intensity
Standard Deviation 2314
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final U1-snRNP A
|
2184 Mean Fluorescence Intensity
Standard Deviation 2701
|
2845 Mean Fluorescence Intensity
Standard Deviation 7385
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final U1-snRNP C
|
657 Mean Fluorescence Intensity
Standard Deviation 819
|
502 Mean Fluorescence Intensity
Standard Deviation 276
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final U1-snRNP B/B
|
260 Mean Fluorescence Intensity
Standard Deviation 110
|
247 Mean Fluorescence Intensity
Standard Deviation 92
|
|
Fluorescence Intensity (FI) of Autoantibodies in Serum
Final Vimentin
|
3160 Mean Fluorescence Intensity
Standard Deviation 1670
|
3891 Mean Fluorescence Intensity
Standard Deviation 1542
|
SECONDARY outcome
Timeframe: Measured at up to 96 weeks or final visitPopulation: Only patients who completed the exams are analyzed.
Snellen visual acuity measured in right and left eyes Scale 10 to 50 with higher numbers indicating lower visual acuity Number of participants with each level of visual acuity in right eye and left eye are counted in the two groups at the final visit
Outcome measures
| Measure |
Hydroxychloroquine
n=52 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=55 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Right Eye · Missing data
|
6 Participants
|
7 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Right Eye · 10
|
0 Participants
|
0 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Right Eye · 15
|
4 Participants
|
6 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Right Eye · 20
|
34 Participants
|
36 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Right Eye · 25
|
6 Participants
|
5 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Right Eye · 30
|
2 Participants
|
1 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Right Eye · 50
|
0 Participants
|
0 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Left eye · Missing data
|
6 Participants
|
7 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Left eye · 10
|
1 Participants
|
0 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Left eye · 15
|
4 Participants
|
6 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Left eye · 20
|
33 Participants
|
38 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Left eye · 25
|
7 Participants
|
2 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Left eye · 30
|
1 Participants
|
1 Participants
|
|
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Left eye · 50
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured at final visit up to 96 weeksPopulation: only patients who completed the exams are shown.
Number of participants with abnormal visual field testing at the final visit.
Outcome measures
| Measure |
Hydroxychloroquine
n=52 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=55 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Ophthalmologic Toxicity by Humphrey Visual Field Testing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at up to 96 weeks or final visitPopulation: only patients who completed exams are shown
Number of participants with abnormal spectral domain ocular coherence tomography at final visit
Outcome measures
| Measure |
Hydroxychloroquine
n=52 Participants
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=55 Participants
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography.
|
0 Participants
|
0 Participants
|
Adverse Events
Hydroxychloroquine
Serious events: 4 serious events
Other events: 83 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 5 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydroxychloroquine
n=92 participants at risk
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 participants at risk
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization Colitis
|
1.1%
1/92 • Number of events 1 • Up to 96 weeks.
|
0.00%
0/88 • Up to 96 weeks.
|
|
Reproductive system and breast disorders
Hospitalization Uterine Fibroids
|
0.00%
0/92 • Up to 96 weeks.
|
1.1%
1/88 • Number of events 1 • Up to 96 weeks.
|
|
Nervous system disorders
Hospitalization Neuropathy
|
1.1%
1/92 • Number of events 1 • Up to 96 weeks.
|
0.00%
0/88 • Up to 96 weeks.
|
|
Infections and infestations
Hospitalization COVID-19
|
0.00%
0/92 • Up to 96 weeks.
|
1.1%
1/88 • Number of events 1 • Up to 96 weeks.
|
|
Blood and lymphatic system disorders
Hospitalization Thromboembolic event
|
0.00%
0/92 • Up to 96 weeks.
|
1.1%
1/88 • Number of events 1 • Up to 96 weeks.
|
|
Gastrointestinal disorders
Hospitalization Cholecystitis
|
1.1%
1/92 • Number of events 1 • Up to 96 weeks.
|
0.00%
0/88 • Up to 96 weeks.
|
|
Nervous system disorders
Hospitalization Radiculitis
|
0.00%
0/92 • Up to 96 weeks.
|
1.1%
1/88 • Number of events 1 • Up to 96 weeks.
|
|
Infections and infestations
Hospitalization Upper respiratory infection
|
0.00%
0/92 • Up to 96 weeks.
|
1.1%
1/88 • Number of events 1 • Up to 96 weeks.
|
|
Surgical and medical procedures
Hospitalization Mastectomy
|
1.1%
1/92 • Number of events 1 • Up to 96 weeks.
|
0.00%
0/88 • Up to 96 weeks.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization Bilateral capsulotomy
|
1.1%
1/92 • Number of events 1 • Up to 96 weeks.
|
0.00%
0/88 • Up to 96 weeks.
|
Other adverse events
| Measure |
Hydroxychloroquine
n=92 participants at risk
Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
Hydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
|
Placebo Oral Capsule
n=88 participants at risk
Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
Placebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Infection
|
12.0%
11/92 • Number of events 11 • Up to 96 weeks.
|
12.5%
11/88 • Number of events 11 • Up to 96 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
6/92 • Number of events 6 • Up to 96 weeks.
|
12.5%
11/88 • Number of events 11 • Up to 96 weeks.
|
|
Infections and infestations
Flu like symptoms
|
9.8%
9/92 • Number of events 9 • Up to 96 weeks.
|
8.0%
7/88 • Number of events 7 • Up to 96 weeks.
|
|
Nervous system disorders
Headache
|
9.8%
9/92 • Number of events 9 • Up to 96 weeks.
|
8.0%
7/88 • Number of events 7 • Up to 96 weeks.
|
|
Infections and infestations
COVID-19 Infection
|
7.6%
7/92 • Number of events 7 • Up to 96 weeks.
|
10.2%
9/88 • Number of events 9 • Up to 96 weeks.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
8/92 • Number of events 8 • Up to 96 weeks.
|
3.4%
3/88 • Number of events 3 • Up to 96 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
5/92 • Number of events 5 • Up to 96 weeks.
|
6.8%
6/88 • Number of events 6 • Up to 96 weeks.
|
|
Infections and infestations
Urinary Tract Infection
|
5.4%
5/92 • Number of events 5 • Up to 96 weeks.
|
6.8%
6/88 • Number of events 6 • Up to 96 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.4%
5/92 • Number of events 5 • Up to 96 weeks.
|
5.7%
5/88 • Number of events 5 • Up to 96 weeks.
|
|
Infections and infestations
Sinusitis
|
6.5%
6/92 • Number of events 6 • Up to 96 weeks.
|
4.5%
4/88 • Number of events 4 • Up to 96 weeks.
|
|
Reproductive system and breast disorders
Vaginal infection
|
5.4%
5/92 • Number of events 5 • Up to 96 weeks.
|
5.7%
5/88 • Number of events 5 • Up to 96 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/92 • Number of events 2 • Up to 96 weeks.
|
8.0%
7/88 • Number of events 7 • Up to 96 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
5/92 • Number of events 5 • Up to 96 weeks.
|
4.5%
4/88 • Number of events 4 • Up to 96 weeks.
|
Additional Information
Nancy J Olsen MD, Professor of Medicine
Penn State Hershey College of Medicine
Phone: 717-531-4921
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place