Systemic Lupus Erythematosus
Conditions
Keywords
hydroxychloroquine
Brief summary
This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial that is designed to test whether treating patients who are at risk for development of lupus with hydroxychloroquine can slow accumulation of disease features. Effects on clinical progression of symptoms, patient-reported outcomes and changes in the immune markers of response will be measured and toxicity of the treatment will be assessed. This trial is a first step in testing a prevention strategy for lupus.
Detailed description
Systemic lupus erythematosus (SLE) causes major organ damage and shortens lifespan in relatively young persons. Early diagnosis and treatment are essential to improving outcomes for SLE patients. However, evidenced-based approaches to early treatment interventions and the appropriate target population for these interventions are not available. We propose that individuals who have positivity for antinuclear antibodies (ANAs) and who also exhibit some of the other features that are used to classify SLE, are at high risk of progressing to the full systemic form of this disease. These individuals, who have significant levels of ANA with 1 or 2 additional items from the lupus classification criteria, are considered to have incomplete lupus erythematosus (ILE). We propose to treat ILE patients with hydroxychloroquine (HCQ) in the Study of Anti-Malarials in Incomplete Lupus Erythematosus or SMILE trial. The primary objective is to determine whether HCQ treatment can prevent acquisition of additional clinical and immunologic features that define SLE. The major secondary objectives are to determine whether HCQ treatment: (1) lessens lupus disease activity as measured by standard scoring indices; (2) improves patient reported outcomes (3) prevents accumulation of immunologic abnormalities including autoantibodies and cytokines and (4) has an acceptable toxicity profile. The specific aims of this proposal are: 1. To carry out a double-blind, placebo-controlled, multicenter, randomized trial of HCQ vs. placebo in patients with ILE. The study tests the hypothesis that early use of HCQ can modify disease features so that accumulation of abnormalities leading to a classification of SLE can be significantly slowed. 2. To determine effects of HCQ on disease activity and patient-reported outcomes in patients with ILE. 3. To characterize the immunologic profile of HCQ in ILE-treated patients. Autoantibodies, cytokines and chemokines will be measured on multiplex arrays for developing insights into underlying mechanisms. 4. To quantitatively assess the incidence of ophthalmologic toxicity in HCQ-treated ILE patients. All enrolled patients will have standardized ophthalmologic examinations before and after study treatment. Recommendations for use and monitoring in this patient population will be developed. The SMILE trial will determine whether or not HCQ should be given to ILE patients, will provide insights into the appropriate target population, and will propose candidate biomarkers to guide treatment decisions. While not part of the Precision Medicine Initiative®, SMILE is consistent with its goals. It will be the first step towards testing the feasibility of disease prevention studies in SLE and will accumulate biological samples in a repository that will be available to the lupus research community for further in-depth mechanistic studies.
Interventions
DRUGHydroxychloroquine
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.
DRUGPlacebo Oral Capsule
An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
1. Between 15 and 49 years of age, inclusive, at Visit 1. 2. Anti-nuclear antibody (ANA) titer of 1:80, or greater, as determined by immunofluorescence assay (IFA). 3. Participants must have at least one (but not three or more) additional clinical or laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. 4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion criteria
1. The subject meets the 2012 SLICC classification criteria for SLE at Visit 1 (i.e., ANA plus 3 other criteria, or ANA plus biopsy-proven lupus nephritis). 2. The subject has been diagnosed with another autoimmune disorder, other than autoimmune thyroid conditions. 3. The subject has fibromyalgia, based on clinical history and exam. 4. The subject has previously been or is currently being treated with oral antimalarial agents including hydroxychloroquine, chloroquine, or quinacrine. 5. The subject is currently or has been treated with immunosuppressive, immune modifying, or cytotoxic medications as listed in Section 7.2. 6. Use of any investigational agent within the preceding 12 months. 7. History of primary immunodeficiency. 8. Active bacterial, viral, fungal, or opportunistic infection. 9. Evidence of infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C. 10. Concomitant malignancy or history of malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. 11. The subject has significant findings on ophthalmological examination that, in the opinion of the examining Ophthalmologist, prevent safe use of hydroxychloroquine. 12. The subject has other contraindications to treatment with hydroxychloroquine including pre-existing ocular disease, hepatic impairment, psoriasis, porphyria, or allergy to the drug or class. 13. Co-morbidities requiring systemic corticosteroid therapy greater than 10 mg of prednisone per day, or equivalent, or a change in corticosteroid dose within the 3 months prior to Visit 1. 14. Starting, stopping, or changing the dose of over the counter or prescription non-steroidal anti-inflammatory drugs (NSAIDs) in the three months prior to Visit 1. 15. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 16. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. 17. Inability to comply with the study visit schedule and procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SLICC Score | Measured every 12 weeks for 96 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Disease Progression | Measured up to 96 weeks. | The number of subjects who progressed from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria. |
| Number of Subjects Meeting Disease Activity Scores Defined Below | Measured every 12 weeks for 96 weeks. | Disease activity measured by the SLE Disease Activity Index Minimum score = 0 Maximum score = 105 Higher scores indicate greater activity of lupus disease |
| Count of Participants With Defined Disease Activity | Measured every 12 weeks for 96 weeks | Disease activity measured by the Cutaneous Lupus Erythematosus Disease Activity Index Minimum score = 0 Maximum score = 70 Higher scores indicate greater cutaneous lupus activity |
| Patient Reported Outcome Physical Function | Measured every 12 weeks for 96 weeks | 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 |
| Patient Reported Outcomes Fatigue | Measured every 12 weeks for up to 96 weeks | 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 |
| Physician Global Asssessment | Measured every 12 weeks for up to 96 weeks | Physician Global Visual Analogue Scale Minimum score = 0 Maximum score = 1.0 Higher scores indicate worse status |
| Fluorescence Intensity (FI) of Autoantibodies in Serum | Measured at baseline and final visit up to 96 weeks. | 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. |
| Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Measured at up to 96 weeks or final visit | 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 |
| Ophthalmologic Toxicity by Humphrey Visual Field Testing | Measured at final visit up to 96 weeks | Number of participants with abnormal visual field testing at the final visit. |
| Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography. | Measured at up to 96 weeks or final visit | Number of participants with abnormal spectral domain ocular coherence tomography at final visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 92 |
| 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. | 88 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Achieved SLE and Concomitant Meds | 1 | 0 |
| Overall Study | Achieved SLE Diagnosis | 11 | 10 |
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Concomitant Medications | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Pregnancy | 2 | 2 |
| Overall Study | Protocol Violation | 1 | 6 |
| Overall Study | Withdrawal by Subject | 26 | 21 |
Baseline characteristics
| Characteristic | Placebo Oral Capsule | Total | Hydroxychloroquine |
|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 8.58 | 33.1 years STANDARD_DEVIATION 9.18 | 32.8 years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 31 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 148 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 22 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 66 Participants | 134 Participants | 68 Participants |
| Region of Enrollment United States | 88 participants | 180 participants | 92 participants |
| Sex: Female, Male Female | 80 Participants | 164 Participants | 84 Participants |
| Sex: Female, Male Male | 8 Participants | 16 Participants | 8 Participants |
| Systemic Lupus International Cooperating Clinics (SLICC) score baseline 2 criteria | 56 Number of criteria | 118 Number of criteria | 62 Number of criteria |
| Systemic Lupus International Cooperating Clinics (SLICC) score baseline 3 criteria | 32 Number of criteria | 62 Number of criteria | 30 Number of criteria |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 88 |
| other Total, other adverse events | 83 / 92 | 85 / 88 |
| serious Total, serious adverse events | 4 / 92 | 5 / 88 |
Outcome results
Primary
SLICC Score
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.
Time frame: Measured every 12 weeks for 96 weeks.
Population: Analysis at each timepoint includes only the number patients who were still active in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : 84 weeks | 21 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : 60 weeks | 28 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : 48 weeks | 30 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : 72 weeks | 26 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : 96 weeks | 21 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : 84 weeks | 22 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : 12 weeks | 46 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : 96 weeks | 24 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : baseline | 30 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : baseline | 0 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : 60 weeks | 23 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : 12 weeks | 0 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : 12 weeks | 33 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : 24 weeks | 3 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : 36 weeks | 31 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : 36 weeks | 1 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : 24 weeks | 32 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : 48 weeks | 2 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : 72 weeks | 21 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : 60 weeks | 3 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : 36 weeks | 29 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : 72 weeks | 2 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : 24 weeks | 35 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : 84 weeks | 2 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 3 : 48 weeks | 24 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 4 or more : 96 weeks | 0 participants |
| Hydroxychloroquine | SLICC Score | SLICC score of 2 : baseline | 62 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : 96 weeks | 2 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : baseline | 56 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : 12 weeks | 41 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : 24 weeks | 40 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : 36 weeks | 34 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : 48 weeks | 29 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : 60 weeks | 26 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : 72 weeks | 24 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : 84 weeks | 22 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 2 : 96 weeks | 22 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : baseline | 32 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : 12 weeks | 31 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : 24 weeks | 27 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : 36 weeks | 25 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : 48 weeks | 25 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : 60 weeks | 23 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : 72 weeks | 21 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : 84 weeks | 25 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 3 : 96 weeks | 26 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : baseline | 0 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : 12 weeks | 2 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : 24 weeks | 4 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : 36 weeks | 3 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : 48 weeks | 1 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : 60 weeks | 0 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : 72 weeks | 0 participants |
| Placebo Oral Capsule | SLICC Score | SLICC score of 4 or more : 84 weeks | 0 participants |
Comparison: For the primary outcome (SLICC classification criteria count \[SLICC score\]), measured every 12 weeks over a 96-week period, we used an ordinal logistic regression model to compare the estimated slopes over time for the intervention (HCQ) and placebo groups. The model accounted for the ordinal and non-decreasing properties of the SLICC score. Our null hypothesis was that the intervention slope equaled the placebo slope, with a corresponding hypothesis that the slopes were not equal.p-value: 0.72Regression, Logistic
Secondary
Count of Participants With Defined Disease Activity
Disease activity measured by the Cutaneous Lupus Erythematosus Disease Activity Index Minimum score = 0 Maximum score = 70 Higher scores indicate greater cutaneous lupus activity
Time frame: Measured every 12 weeks for 96 weeks
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Baseline | Missing data | 0 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Baseline | Score 0 | 67 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Baseline | Score 1 | 9 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Baseline | Score 2 | 8 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Baseline | Score 3 or higher | 8 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 12 | Missing data | 4 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 12 | Score 0 | 59 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 12 | Score 1 | 8 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 12 | Score 2 | 3 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 12 | Score 3 or higher | 8 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 24 | Missing data | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 24 | Score 0 | 52 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 24 | Score 1 | 9 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 24 | Score 2 | 3 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 24 | Score 3 or higher | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 36 | Missing data | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 36 | Score 0 | 50 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 36 | Score 1 | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 36 | Score 2 | 3 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 36 | Score 3 or higher | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 48 | Missing data | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 48 | Score 0 | 45 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 48 | Score 1 | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 48 | Score 2 | 2 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 48 | Score 3 or higher | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 60 | Missing data | 3 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 60 | Score 0 | 42 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 60 | Score 1 | 7 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 60 | Score 2 | 3 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 60 | Score 3 or higher | 4 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 72 | Missing data | 2 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 72 | Score 0 | 42 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 72 | Score 1 | 3 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 72 | Score 2 | 3 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 72 | Score 3 or higher | 1 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 84 | Missing data | 4 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 84 | Score 0 | 39 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 84 | Score 1 | 2 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 84 | Score 2 | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 84 | Score 3 or higher | 0 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 96 | Missing data | 1 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 96 | Score 0 | 36 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 96 | Score 1 | 5 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 96 | Score 2 | 4 Participants |
| Hydroxychloroquine | Count of Participants With Defined Disease Activity | Week 96 | Score 3 or higher | 1 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 48 | Score 1 | 4 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Baseline | Missing data | 0 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 84 | Score 3 or higher | 2 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Baseline | Score 0 | 66 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 48 | Score 2 | 2 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Baseline | Score 1 | 10 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 72 | Score 3 or higher | 2 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Baseline | Score 2 | 9 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 48 | Score 3 or higher | 5 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Baseline | Score 3 or higher | 3 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 96 | Score 1 | 3 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 12 | Missing data | 6 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 60 | Missing data | 5 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 12 | Score 0 | 51 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 84 | Missing data | 3 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 12 | Score 1 | 10 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 60 | Score 0 | 38 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 12 | Score 2 | 7 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 96 | Missing data | 0 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 12 | Score 3 or higher | 5 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 60 | Score 1 | 4 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 24 | Missing data | 3 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 84 | Score 0 | 40 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 24 | Score 0 | 61 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 60 | Score 2 | 3 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 24 | Score 1 | 3 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 96 | Score 3 or higher | 2 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 24 | Score 2 | 5 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 60 | Score 3 or higher | 4 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 24 | Score 3 or higher | 4 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 84 | Score 1 | 1 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 36 | Missing data | 4 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 72 | Missing data | 5 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 36 | Score 0 | 49 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 96 | Score 0 | 43 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 36 | Score 1 | 4 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 72 | Score 0 | 40 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 36 | Score 2 | 5 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 84 | Score 2 | 4 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 36 | Score 3 or higher | 5 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 72 | Score 1 | 1 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 48 | Missing data | 3 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 96 | Score 2 | 2 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 48 | Score 0 | 44 Participants |
| Placebo Oral Capsule | Count of Participants With Defined Disease Activity | Week 72 | Score 2 | 2 Participants |
Comparison: For analysis, we combined responses ≥3 to model the following groups:~* Score of 0~* Score of 1~* Score of 2~* Score of 3 or higherp-value: 0.77Regression, Logistic
Secondary
Fluorescence Intensity (FI) of Autoantibodies in Serum
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final tTg | 6381 Mean Fluorescence Intensity | Standard Deviation 3164 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Vimentin | 3160 Mean Fluorescence Intensity | Standard Deviation 1670 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline NRP1 | 23735 Mean Fluorescence Intensity | Standard Deviation 20781 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final CENP-A | 1243 Mean Fluorescence Intensity | Standard Deviation 1222 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline IL-17A | 9991 Mean Fluorescence Intensity | Standard Deviation 6075 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final CENP-B | 5454 Mean Fluorescence Intensity | Standard Deviation 3029 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Nucleolin | 3108 Mean Fluorescence Intensity | Standard Deviation 2148 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final dsDNA | 2582 Mean Fluorescence Intensity | Standard Deviation 4289 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Genomic DNA | 4484 Mean Fluorescence Intensity | Standard Deviation 7821 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Genomic DNA | 3362 Mean Fluorescence Intensity | Standard Deviation 2458 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Nucleosome | 3017 Mean Fluorescence Intensity | Standard Deviation 1661 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Histone | 2145 Mean Fluorescence Intensity | Standard Deviation 1703 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline KU. (P70/P80) | 3933 Mean Fluorescence Intensity | Standard Deviation 5283 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final IFN-alpha | 2049 Mean Fluorescence Intensity | Standard Deviation 1960 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline NXP2 | 3765 Mean Fluorescence Intensity | Standard Deviation 2275 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final IFN-gamma | 9373 Mean Fluorescence Intensity | Standard Deviation 7330 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline CENP-B | 5461 Mean Fluorescence Intensity | Standard Deviation 2703 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final IL-17A | 9953 Mean Fluorescence Intensity | Standard Deviation 5816 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline PL-7 | 2681 Mean Fluorescence Intensity | Standard Deviation 1335 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Ku P70/P80 | 3967 Mean Fluorescence Intensity | Standard Deviation 5697 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline La/SSB | 4682 Mean Fluorescence Intensity | Standard Deviation 9508 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final La/SS-B | 4703 Mean Fluorescence Intensity | Standard Deviation 10076 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline PL-12 | 6040 Mean Fluorescence Intensity | Standard Deviation 2533 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Laminin | 15573 Mean Fluorescence Intensity | Standard Deviation 16455 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline HIstone | 2349 Mean Fluorescence Intensity | Standard Deviation 2118 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline PM/SCL-100 | 2967 Mean Fluorescence Intensity | Standard Deviation 2631 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final U1-snRNP A | 2184 Mean Fluorescence Intensity | Standard Deviation 2701 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Laminin | 16234 Mean Fluorescence Intensity | Standard Deviation 17545 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final U1-snRNP C | 657 Mean Fluorescence Intensity | Standard Deviation 819 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Ro/SSA 60 KDA | 1800 Mean Fluorescence Intensity | Standard Deviation 4705 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final U1-snRNP B/B | 260 Mean Fluorescence Intensity | Standard Deviation 110 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline CENP-A | 1319 Mean Fluorescence Intensity | Standard Deviation 869 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Vimentin | 3160 Mean Fluorescence Intensity | Standard Deviation 1670 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Scl-70 | 1596 Mean Fluorescence Intensity | Standard Deviation 1499 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Liver Cytosol 1 | 3267 Mean Fluorescence Intensity | Standard Deviation 3074 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Liver Baseline Cytosol ' | 3563 Mean Fluorescence Intensity | Standard Deviation 3632 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final LKM 1 | 2903 Mean Fluorescence Intensity | Standard Deviation 1151 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Sm | 1347 Mean Fluorescence Intensity | Standard Deviation 1677 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final MDA5 | 3483 Mean Fluorescence Intensity | Standard Deviation 3476 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline IFN-alpha | 1813 Mean Fluorescence Intensity | Standard Deviation 1619 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Mi-2 | 1067 Mean Fluorescence Intensity | Standard Deviation 679 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline thyroglobulin | 4211 Mean Fluorescence Intensity | Standard Deviation 7237 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Nrp1 | 24296 Mean Fluorescence Intensity | Standard Deviation 21025 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | baseline LKM 1 | 3067 Mean Fluorescence Intensity | Standard Deviation 1321 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Nucleolin | 2748 Mean Fluorescence Intensity | Standard Deviation 1576 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline TPO | 7986 Mean Fluorescence Intensity | Standard Deviation 9281 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Nucleosome | 2800 Mean Fluorescence Intensity | Standard Deviation 1255 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline dsDNA | 2838 Mean Fluorescence Intensity | Standard Deviation 2766 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final NXP2 | 3584 Mean Fluorescence Intensity | Standard Deviation 2228 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline tTG | 6966 Mean Fluorescence Intensity | Standard Deviation 4280 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final PL-7 | 2352 Mean Fluorescence Intensity | Standard Deviation 973 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline MDA5 | 3725 Mean Fluorescence Intensity | Standard Deviation 4064 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final PL-12 | 5672 Mean Fluorescence Intensity | Standard Deviation 1905 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline U1-snRNPA | 2372 Mean Fluorescence Intensity | Standard Deviation 2869 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final PM/Scl 100 | 2650 Mean Fluorescence Intensity | Standard Deviation 1919 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline IFN-gamma | 9092 Mean Fluorescence Intensity | Standard Deviation 6184 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Ro/SS-A 60 Kda | 1879 Mean Fluorescence Intensity | Standard Deviation 5617 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline U1-snRNP C | 657 Mean Fluorescence Intensity | Standard Deviation 819 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Scl-70 | 1569 Mean Fluorescence Intensity | Standard Deviation 1231 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Mi-2 | 1140 Mean Fluorescence Intensity | Standard Deviation 760 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Sm | 1135 Mean Fluorescence Intensity | Standard Deviation 1087 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline U1-snRNP B/B | 260 Mean Fluorescence Intensity | Standard Deviation 110 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Thyroglobulin | 2933 Mean Fluorescence Intensity | Standard Deviation 4782 |
| Hydroxychloroquine | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final TPO | 6769 Mean Fluorescence Intensity | Standard Deviation 7279 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Thyroglobulin | 3651 Mean Fluorescence Intensity | Standard Deviation 6602 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final TPO | 6873 Mean Fluorescence Intensity | Standard Deviation 4793 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline CENP-A | 1243 Mean Fluorescence Intensity | Standard Deviation 1222 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline CENP-B | 5454 Mean Fluorescence Intensity | Standard Deviation 3029 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline dsDNA | 2582 Mean Fluorescence Intensity | Standard Deviation 4289 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Genomic DNA | 3362 Mean Fluorescence Intensity | Standard Deviation 2458 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline HIstone | 2145 Mean Fluorescence Intensity | Standard Deviation 1703 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline IFN-alpha | 2049 Mean Fluorescence Intensity | Standard Deviation 1960 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline IFN-gamma | 9373 Mean Fluorescence Intensity | Standard Deviation 7330 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline IL-17A | 9953 Mean Fluorescence Intensity | Standard Deviation 5816 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline KU. (P70/P80) | 3967 Mean Fluorescence Intensity | Standard Deviation 5697 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline La/SSB | 4703 Mean Fluorescence Intensity | Standard Deviation 10076 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Laminin | 15573 Mean Fluorescence Intensity | Standard Deviation 16455 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Liver Baseline Cytosol ' | 3267 Mean Fluorescence Intensity | Standard Deviation 3074 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | baseline LKM 1 | 2903 Mean Fluorescence Intensity | Standard Deviation 1151 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline MDA5 | 3483 Mean Fluorescence Intensity | Standard Deviation 3476 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Mi-2 | 1067 Mean Fluorescence Intensity | Standard Deviation 679 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline NRP1 | 24296 Mean Fluorescence Intensity | Standard Deviation 21025 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Nucleolin | 2748 Mean Fluorescence Intensity | Standard Deviation 1576 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Nucleosome | 2800 Mean Fluorescence Intensity | Standard Deviation 1255 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline NXP2 | 3584 Mean Fluorescence Intensity | Standard Deviation 2228 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline PL-7 | 2352 Mean Fluorescence Intensity | Standard Deviation 973 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline PL-12 | 5672 Mean Fluorescence Intensity | Standard Deviation 1905 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline PM/SCL-100 | 2650 Mean Fluorescence Intensity | Standard Deviation 1919 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Ro/SSA 60 KDA | 1879 Mean Fluorescence Intensity | Standard Deviation 5617 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Scl-70 | 1569 Mean Fluorescence Intensity | Standard Deviation 1231 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Sm | 1135 Mean Fluorescence Intensity | Standard Deviation 1087 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline thyroglobulin | 2933 Mean Fluorescence Intensity | Standard Deviation 4782 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline TPO | 6769 Mean Fluorescence Intensity | Standard Deviation 7279 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline tTG | 6381 Mean Fluorescence Intensity | Standard Deviation 3164 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline U1-snRNPA | 2184 Mean Fluorescence Intensity | Standard Deviation 2701 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline U1-snRNP C | 602 Mean Fluorescence Intensity | Standard Deviation 821 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline U1-snRNP B/B | 252 Mean Fluorescence Intensity | Standard Deviation 94 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Baseline Vimentin | 3006 Mean Fluorescence Intensity | Standard Deviation 1140 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final CENP-A | 1889 Mean Fluorescence Intensity | Standard Deviation 7462 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final CENP-B | 6367 Mean Fluorescence Intensity | Standard Deviation 8328 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final dsDNA | 2496 Mean Fluorescence Intensity | Standard Deviation 2472 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Genomic DNA | 3595 Mean Fluorescence Intensity | Standard Deviation 3971 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Histone | 2304 Mean Fluorescence Intensity | Standard Deviation 2636 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final IFN-alpha | 2150 Mean Fluorescence Intensity | Standard Deviation 2096 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final IFN-gamma | 10235 Mean Fluorescence Intensity | Standard Deviation 6071 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final IL-17A | 11656 Mean Fluorescence Intensity | Standard Deviation 6798 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Ku P70/P80 | 4209 Mean Fluorescence Intensity | Standard Deviation 4440 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final La/SS-B | 2881 Mean Fluorescence Intensity | Standard Deviation 1677 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Laminin | 18192 Mean Fluorescence Intensity | Standard Deviation 19262 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final tTg | 6356 Mean Fluorescence Intensity | Standard Deviation 2314 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final U1-snRNP A | 2845 Mean Fluorescence Intensity | Standard Deviation 7385 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final U1-snRNP C | 502 Mean Fluorescence Intensity | Standard Deviation 276 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final U1-snRNP B/B | 247 Mean Fluorescence Intensity | Standard Deviation 92 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Vimentin | 3891 Mean Fluorescence Intensity | Standard Deviation 1542 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Liver Cytosol 1 | 3538 Mean Fluorescence Intensity | Standard Deviation 3506 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final LKM 1 | 3323 Mean Fluorescence Intensity | Standard Deviation 1549 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final MDA5 | 4262 Mean Fluorescence Intensity | Standard Deviation 2636 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Mi-2 | 1299 Mean Fluorescence Intensity | Standard Deviation 736 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Nrp1 | 25597 Mean Fluorescence Intensity | Standard Deviation 22237 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Nucleolin | 3721 Mean Fluorescence Intensity | Standard Deviation 2291 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Nucleosome | 3292 Mean Fluorescence Intensity | Standard Deviation 1595 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final NXP2 | 4598 Mean Fluorescence Intensity | Standard Deviation 2627 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final PL-7 | 2861 Mean Fluorescence Intensity | Standard Deviation 1790 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final PL-12 | 6673 Mean Fluorescence Intensity | Standard Deviation 2873 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final PM/Scl 100 | 2982 Mean Fluorescence Intensity | Standard Deviation 1768 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Ro/SS-A 60 Kda | 1421 Mean Fluorescence Intensity | Standard Deviation 908 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Scl-70 | 2009 Mean Fluorescence Intensity | Standard Deviation 4108 |
| Placebo Oral Capsule | Fluorescence Intensity (FI) of Autoantibodies in Serum | Final Sm | 1858 Mean Fluorescence Intensity | Standard Deviation 5755 |
p-value: >0.05t-test, 2 sided
Secondary
Number of Subjects Meeting Disease Activity Scores Defined Below
Disease activity measured by the SLE Disease Activity Index Minimum score = 0 Maximum score = 105 Higher scores indicate greater activity of lupus disease
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 84 Score 0-1 | 33 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 60 score 2-3 | 11 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 48 Score 0-1 | 35 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 72 Score 2-3 | 13 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 96 Score 0-1 | 29 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 84 Score 2-3 | 9 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 12 Score 0-1 | 44 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 96 Sc ore 2-3 | 10 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Baseline Score 2-3 | 28 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Baseline Score 4-8 | 21 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 60 Score 0-1 | 35 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | week 12 Score 4-8 | 8 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 12 Score 2-3 | 27 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 24 Score 4-8 | 10 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 36 Score 0-1 | 36 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 36 Score 4-8 | 11 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 24 Score 2-3 | 24 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 48 Score 4-8 | 9 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 72 Score 0-1 | 28 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 60 Score 4-8 | 10 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 36 Score 2-3 | 16 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 72 Score 4-8 | 8 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 24 Score 0-1 | 36 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 84 Score 4-8 | 5 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 48 Score 2-3 | 13 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 96 Score 4-8 | 7 Participants |
| Hydroxychloroquine | Number of Subjects Meeting Disease Activity Scores Defined Below | Baseline Score 0-1 | 43 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 96 Score 4-8 | 5 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Baseline Score 0-1 | 45 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 12 Score 0-1 | 37 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 24 Score 0-1 | 45 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 36 Score 0-1 | 38 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 48 Score 0-1 | 36 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 60 Score 0-1 | 32 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 72 Score 0-1 | 34 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 84 Score 0-1 | 35 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 96 Score 0-1 | 36 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Baseline Score 2-3 | 23 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 12 Score 2-3 | 20 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 24 Score 2-3 | 17 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 36 Score 2-3 | 13 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 48 Score 2-3 | 12 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 60 score 2-3 | 9 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 72 Score 2-3 | 6 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 84 Score 2-3 | 8 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 96 Sc ore 2-3 | 9 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Baseline Score 4-8 | 20 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | week 12 Score 4-8 | 16 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 24 Score 4-8 | 11 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 36 Score 4-8 | 12 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 48 Score 4-8 | 7 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 60 Score 4-8 | 8 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 72 Score 4-8 | 5 Participants |
| Placebo Oral Capsule | Number of Subjects Meeting Disease Activity Scores Defined Below | Week 84 Score 4-8 | 4 Participants |
Comparison: For the SLEDAI score, we combined responses to model the following groups:~* Score of 0 or 1~* Score of 2 or 3~* Score of 4, 6, or 8p-value: 0.74Regression, Logistic
Secondary
Number of Subjects With Disease Progression
The number of subjects who progressed from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria.
Time frame: Measured up to 96 weeks.
Population: Analyzed via survival method. TIme to progression, Kaplan Meier.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydroxychloroquine | Number of Subjects With Disease Progression | 12 Participants |
| Placebo Oral Capsule | Number of Subjects With Disease Progression | 12 Participants |
Comparison: Progression to SLE was defined as the number of subjects in whom a SLICC score of 4 was recorded, up to 96 weeks.p-value: 0.81Regression, Cox
Secondary
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
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
Time frame: Measured at up to 96 weeks or final visit
Population: Only patients who completed the exams are analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | Missing data | 6 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 10 | 0 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 15 | 4 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 20 | 34 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 25 | 6 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 30 | 2 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 50 | 0 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | Missing data | 6 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 10 | 1 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 15 | 4 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 20 | 33 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 25 | 7 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 30 | 1 Participants |
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 50 | 0 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 20 | 38 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | Missing data | 7 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | Missing data | 7 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 10 | 0 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 30 | 1 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 15 | 6 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 10 | 0 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 20 | 36 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 25 | 2 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 25 | 5 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 15 | 6 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 30 | 1 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Left eye | 50 | 1 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Snellen Visual Acuity | Right Eye | 50 | 0 Participants |
p-value: >0.5Fisher Exact
Secondary
Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography.
Number of participants with abnormal spectral domain ocular coherence tomography at final visit
Time frame: Measured at up to 96 weeks or final visit
Population: only patients who completed exams are shown
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydroxychloroquine | Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography. | 0 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography. | 0 Participants |
p-value: 1Fisher Exact
Secondary
Ophthalmologic Toxicity by Humphrey Visual Field Testing
Number of participants with abnormal visual field testing at the final visit.
Time frame: Measured at final visit up to 96 weeks
Population: only patients who completed the exams are shown.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydroxychloroquine | Ophthalmologic Toxicity by Humphrey Visual Field Testing | 0 Participants |
| Placebo Oral Capsule | Ophthalmologic Toxicity by Humphrey Visual Field Testing | 0 Participants |
p-value: 1Fisher Exact
Secondary
Patient Reported Outcome Physical Function
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
Time frame: Measured every 12 weeks for 96 weeks
Population: Only patients active at each visit are measured.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydroxychloroquine | Patient Reported Outcome Physical Function | 12 weeks | 49.6 T score | Standard Deviation 7.71 |
| Hydroxychloroquine | Patient Reported Outcome Physical Function | 60 weeks | 49.6 T score | Standard Deviation 8.06 |
| Hydroxychloroquine | Patient Reported Outcome Physical Function | 36 weeks | 48.8 T score | Standard Deviation 8.12 |
| Hydroxychloroquine | Patient Reported Outcome Physical Function | 72 weeks | 49.3 T score | Standard Deviation 8.28 |
| Hydroxychloroquine | Patient Reported Outcome Physical Function | 24 weeks | 49.5 T score | Standard Deviation 7.73 |
| Hydroxychloroquine | Patient Reported Outcome Physical Function | 84 weeks | 49.7 T score | Standard Deviation 7.84 |
| Hydroxychloroquine | Patient Reported Outcome Physical Function | 48 weeks | 48.6 T score | Standard Deviation 8.3 |
| Hydroxychloroquine | Patient Reported Outcome Physical Function | 96 weeks | 48.5 T score | Standard Deviation 8.17 |
| Hydroxychloroquine | Patient Reported Outcome Physical Function | Baseline | 48.5 T score | Standard Deviation 8.26 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | 96 weeks | 50.1 T score | Standard Deviation 7.93 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | Baseline | 48.9 T score | Standard Deviation 7.87 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | 12 weeks | 49.7 T score | Standard Deviation 7.84 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | 24 weeks | 49.4 T score | Standard Deviation 8.42 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | 36 weeks | 49.2 T score | Standard Deviation 8.6 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | 48 weeks | 49.9 T score | Standard Deviation 7.89 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | 60 weeks | 49.4 T score | Standard Deviation 7.92 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | 72 weeks | 50.1 T score | Standard Deviation 8.24 |
| Placebo Oral Capsule | Patient Reported Outcome Physical Function | 84 weeks | 48.7 T score | Standard Deviation 8.55 |
p-value: 0.386t-test, 2 sided
Secondary
Patient Reported Outcomes Fatigue
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
Time frame: Measured every 12 weeks for up to 96 weeks
Population: Only active patients are recorded at each visit. Values represent Fatigue T-scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | 12 weeks | 53.0 T score | Standard Deviation 10.6 |
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | 60 weeks | 51.1 T score | Standard Deviation 11 |
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | 36 weeks | 52.3 T score | Standard Deviation 10.5 |
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | 72 weeks | 50.9 T score | Standard Deviation 11.2 |
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | 24 weeks | 52.2 T score | Standard Deviation 10.2 |
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | 84 weeks | 51.7 T score | Standard Deviation 8.6 |
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | 48 weeks | 51.5 T score | Standard Deviation 10.6 |
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | 96 weeks | 51.9 T score | Standard Deviation 11.3 |
| Hydroxychloroquine | Patient Reported Outcomes Fatigue | Baseline | 54.7 T score | Standard Deviation 10.8 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | 96 weeks | 50.7 T score | Standard Deviation 11 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | Baseline | 55.0 T score | Standard Deviation 10.87 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | 12 weeks | 53.1 T score | Standard Deviation 11.2 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | 24 weeks | 53.2 T score | Standard Deviation 12 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | 36 weeks | 51.8 T score | Standard Deviation 11.4 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | 48 weeks | 51.4 T score | Standard Deviation 11.3 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | 60 weeks | 49.1 T score | Standard Deviation 9.8 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | 72 weeks | 50.3 T score | Standard Deviation 11.2 |
| Placebo Oral Capsule | Patient Reported Outcomes Fatigue | 84 weeks | 51.1 T score | Standard Deviation 10.5 |
p-value: 0.497t-test, 2 sided
Secondary
Physician Global Asssessment
Physician Global Visual Analogue Scale Minimum score = 0 Maximum score = 1.0 Higher scores indicate worse status
Time frame: Measured every 12 weeks for up to 96 weeks
Population: Number of active patients at each time point are measured.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Hydroxychloroquine | Physician Global Asssessment | Baseline | Missing data | 1 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Baseline | Score 0 | 39 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Baseline | Score 0.25 | 35 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Baseline | Score 0.50 | 14 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Baseline | Score 0.75 or higher | 3 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 12 | Missing data | 4 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 12 | Score 0 | 46 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 12 | Score 0.25 | 23 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 12 | Score 0.50 | 4 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 12 | Score 0.75 or higher | 5 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 24 | Missing data | 4 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 24 | Score 0 | 35 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 24 | Score 0.25 | 24 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 24 | Score 0.50 | 9 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 24 | Score 0.75 or higher | 2 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 36 | Missing data | 6 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 36 | Score 0 | 41 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 36 | Score 0.25 | 15 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 36 | Score 0.50 | 5 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 36 | Score 0.75 or higher | 1 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 48 | Missing data | 5 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 48 | Score 0 | 39 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 48 | Score 0.25 | 14 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 48 | Score 0.50 | 4 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 48 | Score 0.75 or higher | 0 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 60 | Missing data | 4 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 60 | Score 0 | 33 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 60 | Score 0.25 | 13 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 60 | Score 0.50 | 7 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 60 | Score 0.75 or higher | 2 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 72 | Missing data | 4 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 72 | Score 0 | 25 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 72 | Score 0.25 | 19 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 72 | Score 0.50 | 3 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 72 | Score 0.75 or higher | 0 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 84 | Missing data | 4 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 84 | Score 0 | 35 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 84 | Score 0.25 | 8 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 84 | Score 0.50 | 3 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 84 | Score 0.75 or higher | 0 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 96 | Missing data | 2 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 96 | Score 0 | 31 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 96 | Score 0.25 | 11 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 96 | Score 0.50 | 2 Participants |
| Hydroxychloroquine | Physician Global Asssessment | Week 96 | Score 0.75 or higher | 1 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 48 | Score 0.25 | 11 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Baseline | Missing data | 1 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 84 | Score 0.75 or higher | 0 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Baseline | Score 0 | 40 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 48 | Score 0.50 | 5 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Baseline | Score 0.25 | 31 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 72 | Score 0.75 or higher | 0 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Baseline | Score 0.50 | 14 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 48 | Score 0.75 or higher | 2 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Baseline | Score 0.75 or higher | 2 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 96 | Score 0.25 | 6 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 12 | Missing data | 7 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 60 | Missing data | 6 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 12 | Score 0 | 39 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 84 | Missing data | 3 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 12 | Score 0.25 | 23 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 60 | Score 0 | 33 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 12 | Score 0.50 | 8 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 96 | Missing data | 1 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 12 | Score 0.75 or higher | 2 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 60 | Score 0.25 | 6 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 24 | Missing data | 4 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 84 | Score 0 | 37 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 24 | Score 0 | 43 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 60 | Score 0.50 | 7 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 24 | Score 0.25 | 19 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 96 | Score 0.75 or higher | 2 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 24 | Score 0.50 | 7 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 60 | Score 0.75 or higher | 2 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 24 | Score 0.75 or higher | 3 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 84 | Score 0.25 | 9 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 36 | Missing data | 6 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 72 | Missing data | 5 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 36 | Score 0 | 34 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 96 | Score 0 | 38 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 36 | Score 0.25 | 16 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 72 | Score 0 | 29 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 36 | Score 0.50 | 7 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 84 | Score 0.50 | 1 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 36 | Score 0.75 or higher | 4 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 72 | Score 0.25 | 15 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 48 | Missing data | 3 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 96 | Score 0.50 | 3 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 48 | Score 0 | 37 Participants |
| Placebo Oral Capsule | Physician Global Asssessment | Week 72 | Score 0.50 | 1 Participants |
p-value: 0.99Regression, Logistic