Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01AR071077 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Active Comparator | 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. |
|
| Placebo oral capsule | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured every 12 weeks for 96 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured up to 96 weeks. |
| Number of Subjects Meeting Disease Activity Scores Defined Below |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy J Olsen, MD | Penn State MS Hershey Medical Center | Principal Investigator |
| David R Karp, MD PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| University of Colorado Anschutz Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30369087 | Background | Karp DR, Chong BF, James JA, Arriens C, Ishimori M, Wallace DJ, Liao D, Olsen NJ. Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1425-1429. doi: 10.1002/acr.23802. | |
| 30572906 | Background | Olsen NJ, James JA, Arriens C, Ishimori ML, Wallace DJ, Kamen DL, Chong BF, Liao D, Chinchilli VM, Karp DR. Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial. Trials. 2018 Dec 20;19(1):694. doi: 10.1186/s13063-018-3076-7. |
Not provided
Not provided
De-identified data will be shared with other investigators upon reasonable request. This will include all patient-level measurements and instruments, as well as the laboratory results.
Data will be available after publication of the primary paper, anticipated in last quarter 2025.
Reasonable request is defined as having a legitimate and specific purpose for use of the data and ability to accept it in a usable format.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population is 180 patients, after excluding 7 patients due to diagnosis of SLE confirmed after delayed labs became available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis at each timepoint includes only the number patients who were still active in the study. | Posted | Number | participants | Measured every 12 weeks for 96 weeks. |
|
Up to 96 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization Colitis | Gastrointestinal disorders | Systematic Assessment | Colitis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
The number of participants was lower than planned in part due to the restrictions that were in place during the COVID-19 pandemic; some sites were closed for a time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy J Olsen MD, Professor of Medicine | Penn State Hershey College of Medicine | 717-531-4921 | nolsen@pennstatehealth.psu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2024 | May 30, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 2, 2024 | May 30, 2025 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Oral Capsule | Drug | An oral capsule placebo is made to match the active intervention medication hydroxychloroquine. |
|
|
Disease activity measured by the SLE Disease Activity Index Minimum score = 0 Maximum score = 105 Higher scores indicate greater activity of lupus disease |
| Measured every 12 weeks for 96 weeks. |
| 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 | Measured every 12 weeks for 96 weeks |
| 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 | Measured every 12 weeks for 96 weeks |
| 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 | Measured every 12 weeks for up to 96 weeks |
| Physician Global Asssessment | Physician Global Visual Analogue Scale Minimum score = 0 Maximum score = 1.0 Higher scores indicate worse status | Measured every 12 weeks for up to 96 weeks |
| 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. | Measured at baseline and final visit up to 96 weeks. |
| 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 | Measured at up to 96 weeks or final visit |
| Ophthalmologic Toxicity by Humphrey Visual Field Testing | Number of participants with abnormal visual field testing at the final visit. | Measured at final visit up to 96 weeks |
| Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography. | Number of participants with abnormal spectral domain ocular coherence tomography at final visit | Measured at up to 96 weeks or final visit |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Penn State MS Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| 34897194 | Derived | Porta SV, Ugarte-Gil MF, Garcia-de la Torre I, Bonfa E, Gomez-Puerta JA, Arnaud L, Cardiel MH, Alarcon GS, Pons-Estel BA, Pons-Estel G. Controversies in Systemic Lupus Erythematosus: Are We Treating Our Patients Adequately? J Clin Rheumatol. 2022 Mar 1;28(2):e651-e658. doi: 10.1097/RHU.0000000000001803. |
| Pregnancy |
|
| Lost to Follow-up |
|
| Concomitant Medications |
|
| Achieved SLE and Concomitant Meds |
|
| Other |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systemic Lupus International Cooperating Clinics (SLICC) score baseline | SLICC scores were determined using the defined list of 17 criteria for classification of SLE. At each visit the list was reviewed and any clinical or laboratory features that satisfied a criterion were counted. This is a cumulative score, which can only increase over time. A higher score indicates more features of lupus have been found. When a score of 4 is reached, then the participant satisfies the classification criteria for SLE. This mandates removal from the trial. | Number | Number of criteria |
|
| OG001 |
| 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. |
|
|
|
| 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. | Analyzed via survival method. TIme to progression, Kaplan Meier. | Posted | Count of Participants | Participants | Measured up to 96 weeks. |
|
|
|
|
| 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 | Count includes number of participants active at each visit. Groups: Score 0-1, Score 2-3, Score 4-8. | Posted | Count of Participants | Participants | Measured every 12 weeks for 96 weeks. |
|
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Measured every 12 weeks for 96 weeks |
|
|
|
|
| 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 | Only patients active at each visit are measured. | Posted | Mean | Standard Deviation | T score | Measured every 12 weeks for 96 weeks |
|
|
|
|
| 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 | Only active patients are recorded at each visit. Values represent Fatigue T-scores. | Posted | Mean | Standard Deviation | T score | Measured every 12 weeks for up to 96 weeks |
|
|
|
|
| Secondary | Physician Global Asssessment | Physician Global Visual Analogue Scale Minimum score = 0 Maximum score = 1.0 Higher scores indicate worse status | Number of active patients at each time point are measured. | Posted | Count of Participants | Participants | Measured every 12 weeks for up to 96 weeks |
|
|
|
|
| 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. | Only patients who completed or who had a defined final visit are included. Samples were measured at baseline and last visit. | Posted | Mean | Standard Deviation | Mean Fluorescence Intensity | Measured at baseline and final visit up to 96 weeks. |
|
|
|
|
| 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 | Only patients who completed the exams are analyzed. | Posted | Count of Participants | Participants | Measured at up to 96 weeks or final visit |
|
|
|
|
| Secondary | Ophthalmologic Toxicity by Humphrey Visual Field Testing | Number of participants with abnormal visual field testing at the final visit. | only patients who completed the exams are shown. | Posted | Count of Participants | Participants | Measured at final visit up to 96 weeks |
|
|
|
|
| Secondary | Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography. | Number of participants with abnormal spectral domain ocular coherence tomography at final visit | only patients who completed exams are shown | Posted | Count of Participants | Participants | Measured at up to 96 weeks or final visit |
|
|
|
|
| 0 |
| 92 |
| 4 |
| 92 |
| 83 |
| 92 |
| EG001 | 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. | 0 | 88 | 5 | 88 | 85 | 88 |
| Hospitalization Uterine Fibroids | Reproductive system and breast disorders | Systematic Assessment | Uterine Fibroids |
|
| Hospitalization Neuropathy | Nervous system disorders | Systematic Assessment | Peripheral sensory neuropathy |
|
| Hospitalization COVID-19 | Infections and infestations | Systematic Assessment | COVID-19 infection |
|
| Hospitalization Thromboembolic event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hospitalization Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization Radiculitis | Nervous system disorders | Systematic Assessment |
|
| Hospitalization Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Hospitalization Mastectomy | Surgical and medical procedures | Systematic Assessment | Right mastectomy, benign |
|
| Hospitalization Bilateral capsulotomy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flu like symptoms | Infections and infestations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| COVID-19 Infection | Infections and infestations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Maculo-papular rash |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Vaginal infection | Reproductive system and breast disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Week 12 Score 0-1 |
|
|
| Week 24 Score 0-1 |
|
|
| Week 36 Score 0-1 |
|
|
| Week 48 Score 0-1 |
|
|
| Week 60 Score 0-1 |
|
|
| Week 72 Score 0-1 |
|
|
| Week 84 Score 0-1 |
|
|
| Week 96 Score 0-1 |
|
|
| Baseline Score 2-3 |
|
|
| Week 12 Score 2-3 |
|
|
| Week 24 Score 2-3 |
|
|
| Week 36 Score 2-3 |
|
|
| Week 48 Score 2-3 |
|
|
| Week 60 score 2-3 |
|
|
| Week 72 Score 2-3 |
|
|
| Week 84 Score 2-3 |
|
|
| Week 96 Sc ore 2-3 |
|
|
| Baseline Score 4-8 |
|
|
| week 12 Score 4-8 |
|
|
| Week 24 Score 4-8 |
|
|
| Week 36 Score 4-8 |
|
|
| Week 48 Score 4-8 |
|
|
| Week 60 Score 4-8 |
|
|
| Week 72 Score 4-8 |
|
|
| Week 84 Score 4-8 |
|
|
| Week 96 Score 4-8 |
|
|
| Score 0 |
|
| Score 1 |
|
| Score 2 |
|
| Score 3 or higher |
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| Week 60 |
|
|
| Week 72 |
|
|
| Week 84 |
|
|
| Week 96 |
|
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 36 weeks |
|
|
| 48 weeks |
|
|
| 60 weeks |
|
|
| 72 weeks |
|
|
| 84 weeks |
|
|
| 96 weeks |
|
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 36 weeks |
|
|
| 48 weeks |
|
|
| 60 weeks |
|
|
| 72 weeks |
|
|
| 84 weeks |
|
|
| 96 weeks |
|
|
| Score 0 |
|
| Score 0.25 |
|
| Score 0.50 |
|
| Score 0.75 or higher |
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| Week 60 |
|
|
| Week 72 |
|
|
| Week 84 |
|
|
| Week 96 |
|
|
| Baseline dsDNA |
|
| Baseline Genomic DNA |
|
| Baseline HIstone |
|
| Baseline IFN-alpha |
|
| Baseline IFN-gamma |
|
| Baseline IL-17A |
|
| Baseline KU. (P70/P80) |
|
| Baseline La/SSB |
|
| Baseline Laminin |
|
| Baseline Liver Baseline Cytosol ' |
|
| baseline LKM 1 |
|
| Baseline MDA5 |
|
| Baseline Mi-2 |
|
| Baseline NRP1 |
|
| Baseline Nucleolin |
|
| Baseline Nucleosome |
|
| Baseline NXP2 |
|
| Baseline PL-7 |
|
| Baseline PL-12 |
|
| Baseline PM/SCL-100 |
|
| Baseline Ro/SSA 60 KDA |
|
| Baseline Scl-70 |
|
| Baseline Sm |
|
| Baseline thyroglobulin |
|
| Baseline TPO |
|
| Baseline tTG |
|
| Baseline U1-snRNPA |
|
| Baseline U1-snRNP C |
|
| Baseline U1-snRNP B/B |
|
| Baseline Vimentin |
|
| Final CENP-A |
|
| Final CENP-B |
|
| Final dsDNA |
|
| Final Genomic DNA |
|
| Final Histone |
|
| Final IFN-alpha |
|
| Final IFN-gamma |
|
| Final IL-17A |
|
| Final Ku P70/P80 |
|
| Final La/SS-B |
|
| Final Laminin |
|
| Final Liver Cytosol 1 |
|
| Final LKM 1 |
|
| Final MDA5 |
|
| Final Mi-2 |
|
| Final Nrp1 |
|
| Final Nucleolin |
|
| Final Nucleosome |
|
| Final NXP2 |
|
| Final PL-7 |
|
| Final PL-12 |
|
| Final PM/Scl 100 |
|
| Final Ro/SS-A 60 Kda |
|
| Final Scl-70 |
|
| Final Sm |
|
| Final Thyroglobulin |
|
| Final TPO |
|
| Final tTg |
|
| Final U1-snRNP A |
|
| Final U1-snRNP C |
|
| Final U1-snRNP B/B |
|
| Final Vimentin |
|
| 15 |
|
| 20 |
|
| 25 |
|
| 30 |
|
| 50 |
|
| Left eye |
|