Rheumatoid Arthritis (RA) Clinical Trial
Official title:
Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)
Verified date | April 2024 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: - Systemic Lupus Erythematosus (SLE) - Juvenile Idiopathic Arthritis (JIA) - Pediatric-Onset Multiple Sclerosis (POMS) - Juvenile Dermatomyositis (JDM)
Status | Completed |
Enrollment | 257 |
Est. completion date | March 28, 2024 |
Est. primary completion date | June 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility | General Adult Inclusion Criteria: 1. Willing and able to sign informed consent 2. Documented full COVID-19 vaccination (CDC card or documentation in medical records) that was completed at least 4 weeks prior and no more than 52 weeks prior to the Stage 1 Screening visit, or if participating in Stage 2, no more than 48 weeks prior to the Stage 2 Screening visit. General Exclusion Criteria 2. History of severe allergic reaction to the initial COVID-19 vaccine regimen, to any component of any of the COVID-19 vaccines, or to polyethylene glycol (PEG). 3. New diagnosis of malignancy that will require chemotherapy or immunotherapy, or ongoing treatment for a malignancy with chemotherapy or immunotherapy. 4. Active disease (per the Investigator's decision) resulting in inability to hold the IS therapy in the MMF/MPA or MTX arms of the study. a. The potential impact of temporarily holding medication for participants with a recent mild disease flare within 4 weeks should be carefully considered. 5. Active disease during the Screening period resulting in: 1. An increase/addition of any IS medications, or 2. A suggestion of MS relapse per the investigator. 6. Recent or current SARS-CoV-2 infection defined as: 1. Documented SARS-CoV-2 infection in the past 30 days (from the day the participant is diagnosed by positive test to Screening). 2. Positive result on a molecular COVID-19 test at Screening. 8. Inflammatory myocarditis/pericarditis within 6 weeks of any COVID-19 vaccine doses. 9. Participants with active, ongoing chronic infections. Note: Participants are permitted to be on chronic prophylactic antimicrobial therapy. Adults with evidence of HIV, Hepatitis B indicated by surface antigen, and Hepatitis C indicated by anti-hepatitis C antibody positivity will be excluded. If an adult is negative for Hepatitis C viral load at Screening, he/she will be eligible to participate. 10. Participants with common variable immunodeficiency disease, as well as any participants currently receiving immune globulin replacement therapy. Note: Pediatric participants on IVIG therapeutically may enter the study provided they have sufficiently quiet disease that they can withhold their IVIG from 8 weeks prior to the Screening visit through 4 weeks after vaccination. 11. Participants who received licensed or investigational monoclonal antibodies or plasma products directed against SARS-CoV-2 within 30 days of Screening. 12. Participants who have received any live vaccines within 2 months of the anticipated study vaccine dose or who will have need of a live vaccine at any time during the study. 13. Currently pregnant or breastfeeding (For pediatric participants postmenarchal females must have a negative urine pregnancy test at Screening). 15. Hemoglobin (Hgb) <8.0 g/dL (80 g/L) 16. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 17. Other investigational chemical agent within 30 days or other investigational biologic agent within 8 weeks or 5 half-lives (whichever is longer) of Screening. 18. Concurrent treatment with cyclophosphamide. Adult participants taking cladribine, alemtuzumab, or mitoxantrone will also be excluded. 19. Participants currently on any type of dialysis, or who have received a solid organ transplant. 20. Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness. 21. Taking both MMF/MPA and MTX. 22. Receiving other investigational BCDT as part of a clinical trial within 18 months of Screening, unless drug assignment is known and the participant received an anti-CD20 or CD19 drug. 23. Participants with active systemic infections who have received systemic antimicrobials within the 14 days prior to Screening. Adult General Criteria Inclusion Criteria: 1. Individuals 18 years of age or older that meet classification criteria for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), rheumatoid arthritis (RA), multiple sclerosis (MS), or pemphigus 2. Participants must meet the 2019 ACR/EULAR or 2012 SLICC classification criteria for SLE, the 2010 ACR/EULAR classification criteria for RA, the 2013 EULAR/ACR classification criteria for SSc, the 2017 McDonald criteria for MS, and the international consensus criteria for pemphigus. 1. If a participant has been diagnosed with more than one autoimmune disease, the participant will be assessed based on the disease that is selected for study entry 6. Must be currently taking one of the following IS medications with or without additional disease-related medications: MMF (minimum of 1000 mg per day)/MPA (minimum of 720 mg per day), MTX (minimum of 7.5mg per week), or B cell depleting agents within the past 18 months (such as rituximab, ocrelizumab, ofatumumab). 1. If taking MMF/MPA or MTX, the participant must have initiated therapy at least 8 weeks prior to randomization and be taking the same medications (regardless of dose) as at the time of the initial COVID-19 vaccine regimen. Note: Participants who withheld their IS medications around their initial vaccinations are eligible to participate. 2. If enrolling in the BCDT cohort, the participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months. 7. No changes in background IS medications, including MMF/MPA or MTX, in the 4 weeks prior to Screening, excluding the following: 1. HCQ, 2. Intraarticular steroids, 3. The addition of prednisone at =10mg per day or prednisone at any dose when given for =3 days, and 4. Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or COPD, are permitted. Adult General Exclusion Criterion 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol. 14. Adult female participants who are planning a pregnancy during the course of the trial. Adult Stage 1-Specific Inclusion Criterion 5. Negative or suboptimal serologic response to initial COVID-19 vaccine regimen, defined as an Elecsys® Anti-SARS-CoV-2 S result =200 U/mL, at Screening visit. 1. Initial COVID-19 vaccine regimen is defined as either: i.2 doses of the Pfizer-BioNTech COVID-19 Vaccine ii. 2 doses of the Moderna COVID-19 Vaccine Adult Stage 1-Specific Exclusion Criterion 7. Receipt of a COVID-19 vaccine booster prior to Screening with the Moderna COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, or Janssen COVID-19 Vaccine. Adult Stage 2 (Newly Recruited)-Specific Inclusion Criteria 2. History of severe allergic reaction to the COVID-19 vaccine, or to any component of the COVID-19 vaccine, that is to be administered in Stage 2, including polysorbate for participants receiving the Sanofi-GSK COVID-19 Vaccine, or to PEG. 5. Negative or suboptimal serologic response to a previous COVID 19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of =200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of =2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows: 1. 3 doses of the Pfizer-BioNTech COVID-19 Vaccine 2. 3 doses of the Moderna COVID-19 Vaccine 3. 2 doses of the Janssen COVID-19 Vaccine 4. 4 or more doses of a single mRNA vaccine (Pfizer-BioNTech COVID-19 Vaccine OR Moderna COVID-19 Vaccine) 5. 3 or more doses of a mixture of mRNA vaccines (Pfizer-BioNTech COVID-19 Vaccine OR Moderna COVID-19 Vaccine) Adult Stage 2 (Newly Recruited)-Specific Exclusion Criteria: 7. Receipt of a mixture of Janssen COVID-19 vaccines and mRNA COVID-19 vaccines (in any order or combination) prior to Stage 2 Screening. Adult Stage 2 (Rollover)-Specific Inclusion Criteria: Individuals who were previously enrolled in Adult Stage 1 or Adult Stage 2 will have met some inclusion and exclusion criteria at that time. Only a subset of the criteria for (re-)entering Adult Stage 2 will be assessed in rollover participants at the time of screening for Stage 2. Individuals who meet all of the following criteria are eligible to (re )enter Adult Stage 2: 2. History of severe allergic reaction to the COVID-19 vaccine, or to any component of the COVID-19 vaccine, that is to be administered in Stage 2, including polysorbate for participants receiving the Sanofi-GSK COVID-19 Vaccine, or to PEG. 5. Negative or suboptimal serologic response to a previous COVID 19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of =200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of =2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows: a. 3 doses of the Pfizer-BioNTech COVID-19 Vaccine b. 3 doses of the Moderna COVID-19 Vaccine c. 2 doses of the Janssen COVID-19 Vaccine d. 4 doses of a combination of mRNA vaccines (i.e., Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine) General Pediatric Inclusion Criteria 1. Individuals 2-17 years of age that meet classification criteria for SLE, JIA, POMS, or JDM. Note: Juvenile idiopathic arthritis includes the following conditions: polyarticular JIA (both RF + and -), oligoarticular persistent and oligoarticular extended JIA, psoriatic arthritis, and enthesitis related JIA. 1. Participants must meet the 2017 EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups, the International League of Associations for Rheumatology (ILAR) classification for JIA, the 2017 McDonald criteria for MS, or the Bohan and Peter criteria or the 2017 EULAR/ACR classification criteria for JDM. 2. If a participant has been diagnosed with more than one autoimmune disease, the participant will be assessed based on the disease that is selected for study entry. 2. Parents/guardians of all pediatric participants and participants ages 14 - 17 must be willing and able to sign informed consent. Participants ages 7-13 must be willing and able to sign assent. 5. Must be currently taking one of the following IS medications with or without additional disease-related medications: MMF (minimum of 250 mg per day)/MPA (minimum of 360 mg per day), MTX (minimum of 5 mg per week), or B cell depleting agents within the past 18 months (such as rituximab, ocrelizumab, or ofatumumab). 1. If taking MMF/MPA or MTX, the participant must have initiated therapy at least 8 weeks prior to randomization and be taking the same medications (regardless of dose) as at the time of the initial COVID-19 vaccine regimen. Note: Participants who withheld their IS medications around their initial vaccinations are eligible to participate. 2. If enrolling in the BCDT cohort, participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months. 6. No changes in background IS medications, including MMF/MPA or MTX, in the 8 weeks prior to Screening, excluding the following: a. HCQ, b. Intraarticular steroids, c. The addition of prednisone at <0.15mg/kg/dose per day or prednisone at any dose when given for =3 days, and d. Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or COPD, are permitted General Pediatric Exclusion Criteria 1. Inability or unwillingness of a participant to give assent or of a parent/guardian to give written informed consent, or of either to comply with study protocol. Pediatric Stage 1-Specific Inclusion Criteria: 4. Negative or suboptimal serologic response to initial EUA-authorized or FDA-approved COVID-19 vaccine doses, defined as an Elecsys® Anti-SARS-CoV-2 S result =200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of =2500 U/mL, within 4 weeks of the Stage 1 Baseline/Week 0 visit Initial COVID-19 vaccine regimen is defined as: i. Pfizer-BioNTech COVID-19 Vaccine (2 through 4 years of age): 3 age-appropriate doses ii. Pfizer-BioNTech COVID-19 Vaccine (5 through 17 years of age): 2 age-appropriate doses iii. Moderna COVID-19 Vaccine (2 through 17 years of age): 2 age-appropriate doses. Pediatric Stage 1-Specific Exclusion Criteria: Individuals who meet any of these criteria are not eligible for randomization/allocation as participants in the pediatric portion of the study: 7. Receipt of a COVID-19 vaccine booster prior to Screening. Pediatric Stage 2 (Newly Recruited)-Specific Inclusion Criteria 5. Negative or suboptimal serologic response to homologous doses of COVID-19 vaccine in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of =200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of =2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows: a. Pfizer-BioNTech COVID-19 Vaccine (2 through 5 years of age): 4 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine b. Pfizer-BioNTech COVID-19 Vaccine (5 through 17 years old): 3 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine Note: Participants who are 5 years old and previously received the Pfizer-BioNTech COVID-19 Vaccine may have received either age-appropriate regimen. c. Moderna COVID-19 Vaccine (12 through 17 years of age): 3 full, age-appropriate doses of the Moderna COVID-19 Vaccine Pediatric Stage 2 (Newly Recruited)-Specific Exclusion Criteria: 7. Receipt of an additional heterologous COVID-19 vaccine dose prior to Stage 2 Screening, i.e., a participant cannot have received a mixture of mRNA vaccines. Pediatric Stage 2 (Rollover)-Specific Inclusion Criteria: 5. Negative or suboptimal serologic response to a previous COVID-19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of =200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of =2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows: 1. Pfizer-BioNTech COVID-19 Vaccine (2 through 5 years of age): 4 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine 2. Pfizer-BioNTech COVID-19 Vaccine (5 through 17 years old): 3 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine Note: Participants who are 5 years old and previously received the Pfizer-BioNTech COVID-19 Vaccine may have received either age-appropriate regimen. 3. Moderna COVID-19 Vaccine (12 through 17 years of age): 3 full, age-appropriate doses of the Moderna COVID-19 Vaccine |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology | Ann Arbor | Michigan |
United States | The Emory Clinic: Division of Rheumatology | Atlanta | Georgia |
United States | Boston Children's Hospital: Department of Pediatrics, Rheumatology Program | Boston | Massachusetts |
United States | Brigham & Women's Hospital: Department of Medicine, Rheumatology, Immunology | Boston | Massachusetts |
United States | Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases | Boston | Massachusetts |
United States | University of North Carolina Children's Hospital | Chapel Hill | North Carolina |
United States | Medical University of South Carolina, Nexus Research Center | Charleston | South Carolina |
United States | Medical University of South Carolina, Shawn Jenkins Children's Hospital | Charleston | South Carolina |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Nationwide Children's Hopspital | Columbus | Ohio |
United States | UT Southwestern (Peds) | Dallas | Texas |
United States | Duke University Medical Center: Division of Rheumatology and Immunology | Durham | North Carolina |
United States | University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics | Houston | Texas |
United States | Indiana University Medical Center, Riley Hospital for Children | Indianapolis | Indiana |
United States | UCLA Medical Center: Division of Rheumatology | Los Angeles | California |
United States | Feinstein Institute for Medical Research | Manhasset | New York |
United States | Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases | Manhasset | New York |
United States | Yale University School of Medicine: Rheumatology, Allergy & Immunology | New Haven | Connecticut |
United States | Columbia University Irving Medical Center: Department of Neurology, Multiple Sclerosis Center | New York | New York |
United States | Hospital for Special Surgery | New York | New York |
United States | New York University Langone Medical Center: Department of Medicine, Division of Rheumatology | New York | New York |
United States | Oklahoma Children's Hospital-Pediatrics Specialties Clinic | Oklahoma City | Oklahoma |
United States | Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program | Oklahoma City | Oklahoma |
United States | Temple Health: Rheumatology | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Washington University School of Medicine in St. Louis: Division of Rheumatology | Saint Louis | Missouri |
United States | Benaroya Research Institute at Virginia Mason: Internal Medicine | Seattle | Washington |
United States | Stony Brook University Hospital | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence, Rho Federal Systems Division, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of adult and pediatric participants who have a protective antibody response at Week 4 | Efficacy measure. | Week 4 Status Post Receipt of COVID-19 Vaccination | |
Secondary | Percentage of Subset Participants Who Seroconverted | Efficacy measure, evaluated in subset of participants who are anti-COVID-19 antibody negative at Baseline. | Baseline (prior to receipt of COVID-19 vaccine booster) and Weeks 4, 12, 24, 36, and 48 | |
Secondary | Fold increase in anti-COVID-19 antibody levels at Week 4, following participant receipt of a booster dose of COVID-19 vaccine | Efficacy measure, evaluated in subset of participants who are anti-COVID-19 antibody positive at Week 0 (Baseline). | Baseline (prior to receipt of COVID-19 vaccine booster), Week 4 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in anti-COVID-19 antibody response | Efficacy measure. | Baseline (prior to receipt of COVID-19 vaccine booster) and Weeks 4, 12, 24, 36, and 48 | |
Secondary | Change in anti-SARS-CoV-2 neutralizing antibody levels | Efficacy measure, employing neutralization and pseudo-neutralization assays. | Baseline (prior to receipt of COVID-19 vaccine booster) and Weeks 4, 12, 24, 36, and 48 | |
Secondary | Change in disease activity after receipt of additional doses of COVID-19 vaccine as measured by the Clinical Global Impression of Change (CGI-C) | A measure of disease activity and efficacy.
CGI-C: Clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Dose | |
Secondary | Change in disease activity after receipt of additional doses of COVID-19 vaccine as measured by the Physician's Global Assessment | A measure of disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in adult participant subset with Systemic Lupus Erythematosus (SLE) as measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | A measure of SLE disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in adult participant subset with Systemic Lupus Erythematosus (SLE) as measured by Thanou modified SELENA-SLEDAI Flare Index for Systemic Lupus Erythematosus (SLE) | A measure of SLE disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 | |
Secondary | Change in disease activity in adult participant subset with Rheumatoid Arthritis (RA) as measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | A measure of RA disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in adult participant subset with Systemic Sclerosis (SSc) as measured by Disease Flare Activity | A measure of SSc disease activity and efficacy.
SSc disease flare assessments (including participant self- reported flare assessment). A flare is indicative of increased SSc-related disease activity. |
Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in adult participant subset with Pemphigus as measured by Disease Area Index (PDAI) for Pemphigus | A measure of pemphigus disease activity and efficacy.
The PDAI is specific cutaneous and mucosal disease activity assessment performed by the physician and is based on evaluation of lesions in well-defined anatomical locations. |
Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in adult participant subset with Multiple Sclerosis (MS) as measured by Physician assessed relapse for MS | A measure of MS disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in pediatric participant subset with juvenile idiopathic arthritis (JIA) as measured by JADAS10 | A measure of JIA disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in pediatric participant subset with JIA as measured by Psoriasis Area and Severity Index (PASI) for psoriatic arthritis | A measure of JIA disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in pediatric participant subset with pediatric-onset multiple sclerosis (POMS) as measured by SLEDAI-2K | A measure of MS disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in pediatric participant subset with POMS as measured by childhood-onset SLE Criteria for Global Flare | A measure of POMS disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in pediatric participant subset with juvenile dermatomyositis (JDM) as measured by Childhood Mysositis Assessment Scale | A measure of JDM disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in pediatric participant subset with JDM as measured by JDM Disease Activity Score (DAS) | A measure of JDM disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in pediatric participant subset with Multiple Sclerosis (MS) as measured by Physician assessed relapse for MS (POMS) | A measure of MS disease activity and efficacy. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in adult participants as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | A measure of disease activity and efficacy. The Patient-Reported Outcomes Measurement Information System (PROMIS-29) self-report assesses functioning and well-being in physical, mental and social domains of health. The PROMIS-29 consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity in pediatric participants as measured by the Pediatric Quality of Life Inventory (PedsQL) | A measure of disease activity and efficacy. The Patient-Reported Outcomes Measurement Information System (PROMIS-29) self-report assesses functioning and well-being in physical, mental and social domains of health. The PROMIS-29 consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Change in disease activity as measured by the Patient Global Assessment | A measure of disease activity and efficacy. The patient global assessment of disease activity is measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose |
| |
Secondary | Change in disease activity as measured by the Patient Global Impression of Change (PGI-C) | A measure of disease activity and efficacy. Participant's Global Impression of Change Reported on PGI-C Scale (1-7 Point Scale Ranging From 1 "Very Much Improved" to 7 "Very Much Worse"). | Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose | |
Secondary | Proportion of participants who experience any solicited Grade 1 or higher adverse events related to additional doses of the COVID-19 vaccine | Safety measure status post receipt of study vaccination. | Through Day 7 post study vaccination | |
Secondary | Proportion of participants who experience any unsolicited Grade 1 or higher adverse events related to additional doses of the COVID-19 vaccine | Safety measure status post receipt of study vaccination. | Through Day 28 post study vaccination | |
Secondary | Proportion of participants who experience any serious adverse events (SAEs) | Safety measure status post receipt of study vaccination. | Up to Week 48 post study vaccination | |
Secondary | Proportion of participants who experience any medically attended adverse events (MAAEs) | Safety measure status post receipt of study vaccination. | Up to Week 48 post study vaccination | |
Secondary | Proportion of participants who experience any New Onset Chronic Medical Conditions (NOCMCs) | Safety measure status post receipt of study vaccination. | Up to Week 48 post study vaccination | |
Secondary | Proportion of participants who experience any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection | Efficacy measure. | Up to Week 48 post study vaccination |
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N/A | |
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