Rheumatoid ArthritisPhase 4RZVRheumNCT05879419
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
A Phase 4 study testing Recombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation and MMF Discontinuation in people with Rheumatoid Arthritis and Spondylitis, Ankylosing, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis
- What is being tested?
- Recombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation and MMF Discontinuation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,005 participants
- Where
- 1 siteBrazil
- Study dates
- 23 May 2023to 30 Jun 2032
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects will be adults (≥18 years-old).
- ARD patients will be selected from patients regularly followed up at the Outpatient Rheumatology Clinics of the Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil, according to the specific classification criteria: RA (Aletaha et al., 2010), SLE (Petri et al., 2012), pSS (Vitali et al., 2002), SSc (van den Hoogen et al., 2013), IIM (Lundberg et al., 2017), axial spondyloarthritis (axSpA) (Rudwaleit et al., 2009), PsA (Tillett et al., 2012) and granulomatosis with polyangiitis (Leavitt et al., 1990).
- Patients must be under current use of cyclophosphamide, mycophenolate mofetil, azathioprine, cyclosporin, tacrolimus, leflunomide, glucocorticoids, methotrexate, biologic therapy or JAKi with or without csDMARDs for at least one month prior to study inclusion.
Who cannot join
- history of any reaction or hypersensitivity to any component of the vaccine;
- previous HZ vaccination;
- any occurrence of Guillain-Barré syndrome;
- hospitalization, acute infectious disease or fever at the time of vaccination;
- pregnancy or lactation at the time of vaccination;
- history of HZ within the 12 months preceding the first dose of study vaccine;
- people living with HIV/AIDS (PLWHA).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Efficacy, Immunogenicity and Safety of Recombinant Vaccine Against Herpes Zoster (RZV or SHINGRIX®) in Patients With Autoimmune Rheumatic Diseases
Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM) and primary vasculitides, have a high risk of herpes zoster (HZ) infection. This increased susceptibility is caused by a deficient cell-mediated immune response due to the underlying disease and glucocorticoid and immunosuppressive treatments that impair the T-cell response, including conventional and unconventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biological agents. In this context, the recent availability of a recombinant vaccine against HZ (RZV or Shingrix®), composed of recombinant VZV glycoprotein E (gE) and the AS01B adjuvant system (HZ/su), is a major progress regarding safety for immunosuppressed patients. Its effectiveness, however, has been clearly demonstrated for non-immunosuppressed patients and in selected populations of immunocompromised individuals. There are no prospective controlled studies evaluating the immunogenicity of RZV and its impact on the activity of the underlying disease, as well as its safety in patients with ARDs at high-risk for HZ.
Hypothesis: RZV has a good safety profile, including with respect to underlying rheumatic disease activity, in patients with ARDs at high risk of HZ.
Read more
Objectives: Primary: To assess the short-term safety profile in relation to underlying disease activity in patients with ARDs at high risk of HZ immunized with RZV compared to unvaccinated patients. Secondary: To evaluate the general safety of the vaccine in patients with ARDs at high risk of HZ immunized with RZV and non-immunosuppressed control subjects (CG); the humoral and cellular immunogenicity of RZV in patients with ARDs at high risk of HZ compared to CG; the influence of disease treatment on vaccine response; the 12-month persistence of humoral immunogenicity and incident cases of HZ. Specific studies will also be carried out to evaluate the effect of drug withdrawal (methotrexate-MTX and mycophenolate mofetil-MMF) after vaccination in increasing the immune response in patients with ARDs with controlled underlying disease.
On November 19, 2025, the institutional Ethics Committee approved an amendment to extend the project's timeframe to evaluate the following hypothesis:
- Immunosuppression may hamper 5-year long-term sustainability of humoral and cellular immune responses to RZV in ARD patients.
No new patients will be recruited, nor will any new intervations be performed. ARD patients previously included in the study and non-immunosuppressed control subjects who received both vaccine doses and collected samples for immunogenicity 6 weeks and one year after the second dose will be part of the proposed extension. A total of 1,025 ARD patients enrolled and 365 healthy controls will be included in the long-term follow-up phase. Considering a conservative 10% dropout, the final patient sample will be approximately 1,000.
Ethical statement: The extension protocol was approved by the institutional Ethics Committee (report 7.988.896), and written consent will be obtained from all participants prior to inclusion. Humoral immunogenicity will be evaluated by analyzing the serum concentrations of anti-gE antibodies (ELISA) of blood samples collected from participants at 5-year after complete VZR vaccination, as previously described (Cunningham et al., 2018). Cellular immunogenicity will be evaluated in a convenience sample (20% of the total research participants) of patients with ARDs and healthy controls at 5-year after complete VZR vaccination. Vaccine efficacy will be evaluated by incident cases of HZ in the period of 5 years after RZV vaccination. Participants will be followed for 5 years after the second RZV dose through monthly contacts and routine clinical visits every 3-6 months.
Read the detailed description
Methods:
Subproject A: This is a phase 4 randomized prospective study of adult patients with ARDs who will receive two intramuscular doses of RZV 6 weeks apart. A control group of non-immunosuppressed individuals (CG) aged ≥ 50 years will also be included, in the proportion of 3 patients:1 control. Patients with ARDs will be randomly allocated into two groups: P1 and P2. CG and P1 will receive the vaccine soon after randomization, on D0 and D42. P2 will be vaccinated 12 weeks after randomization, on D84 and D126. All groups will collect blood samples immediately before vaccination, at baseline, and then receive the 1st dose of vaccine on the same day (D0 for CG and P1, and D84 for P2). The second dose will be applied 6 weeks after the first dose (D42 for P1 and CG, and D126 for P2). Blood samples for disease activity and immunogenicity will be collected 6 weeks after the 2nd dose (D84 for CG and P1 and D168 for P2). The influence of vaccination on disease activity will be evaluated in the first three months of follow-up through disease-specific activity indices. Safety analysis regarding adverse effects (AEs) of the vaccine will be performed using standardized questionnaires on D42 and D84 for CG and P1 and on D126 and D168 for P2. Severe AEs and incident cases of HZ will be evaluated throughout the study period. The persistence of immunogenicity will be evaluated one year after the 2nd dose (D407 for CG and P1, and D491 for P2).
Subproject B: Specific studies will also be carried out to evaluate the effect of drug withdrawal (MTX and MMF) after vaccination in increasing the immune response in patients with ARDs with controlled baseline disease. Randomization of patients with ARDs with well-controlled disease selected for the MTX discontinuation protocol will divide them into two groups: MTX-suspension, in which MTX will be suspended for 2 weeks after each vaccine dose, and another group that will maintain stable therapy (MTX-maintenance), with assessments of immunogenicity and disease activity. The same applies to patients undergoing the MMF discontinuation protocol (but the MMF suspension time will be one week after each vaccine dose). Based on a recently published study (Petri et al., 2023), discontinuation time of the MMF after each vaccine dose was reduced from two weeks to one week. In fact, these authors observed in a cohort of 334 patients with systemic lupus erythematosus that discontinuing MMF for one week after vaccination against COVID-19 (mRNA vaccine) improved vaccine efficacy without leading to exacerbations of the underlying disease (Petri et al., 2023). Thus, we considered it appropriate to reduce the MMF discontinuation time to one week after each dose of the recombinant vaccine for herpes zoster in our population of patients with autoimmune rheumatic diseases.
Total population: The total population will consist of 2005 participants comprising 1180 patients with ARDs (590 in P1 and 590 in P2), 393 healthy controls. 202 patients on the MTX maintenance/discontinuation RA protocol for two weeks after each vaccine dose, and 230 patients with ARDs on the MMF maintenance/discontinuation protocol for one week after each vaccine dose.
Immunogenicity analysis: Humoral immunogenicity will be evaluated through serum concentrations of anti-gE antibodies [enzyme-linked immunosorbent assay (ELISA)] of blood samples collected from participants pre-vaccination, 2 months and one year after the second dose of RZV. The frequencies of gE-specific CD4[2+] T cells will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of the total number of participants) from patients with ARDs and healthy controls.
- Conditions
- Rheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis
- Being tested
- Recombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation, MMF Discontinuation, Placebo, MTX maintain
- Keywords
- Recombinant herpes zoster vaccine, Herpes zoster, Autoimmune rheumatic diseases, Disease activity, Safety, Immunogenicity, Disease-modifying anti-rheumatic drugs, Biological disease-modifying anti-rheumatic drugs, Glucocorticoid
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Spondylarthritis, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Scleroderma, Systemic, Myositis, Systemic Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Herpes Zoster Vaccine (RZV)Biological
Also called Shingrix®
RZV comprise 50 μg of recombinant VZV glycoprotein E and the liposome-based AS01B adjuvant system (which contains 50 μg of 3-O-desacyl-4'-monophosphoryl lipid A [MPL] and 50 μg of Quillaja saponaria Molina, fraction 21 (QS21, licensed by GSK from Antigenics, a subsidiary of Agenus)). Vaccine will be administered (0.5 ml) into the deltoid muscle at inclusion and 6 weeks (two doses).
MTX DiscontinuationOther
Evaluation of discontinuation of the use of methotrexate (MTX) for 2 weeks after each vaccine dose in ARD patients: patients using MTX at a stable dose for at least 12 weeks, prednisone maximum dose of 5 mg/day, in association or not with other drugs except rituximab will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MTX for 2 weeks after each vaccine dose (MTX-withhold) and other that will maintain stable therapy (MTX-maintain).
MMF DiscontinuationOther
Evaluation of discontinuation of the use of mycophenolate mofetil (MMF) for one week after each vaccine dose in ARD patients: patients using MMF at a stable dose for at least 12 weeks, prednisone maximum dose of 7.5 mg/day, not associated with other immunosuppressive therapy, will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MMF for 2 weeks after each vaccine dose (MMF-withhold) and other that will maintain stable therapy (MMF-maintain).
PlaceboOther
Patients with ARDs who received the placebo at study entry (P2). ARD patients will be randomly assigned in a 1:1 ratio, with the use of an automated Web and telephone system, to one of two subgroups: P1, patients allocated to receive vaccine right after randomization (at D0 and D42), and P2, patients allocated to receive placebo at D0 and D42. Subsequently, blindness will be broken at D84 and P2 patients will receive vaccine doses at the D84 and D126.
MTX maintainOther
MTX dose will be held stable after the two vaccine doses for comparison of vaccine immunogenicity and disease activity with the MTX-withhold group.
MMF maintainOther
MMF dose will be held stable after the two vaccine doses for comparison of vaccine immunogenicity and disease activity with the MMF-withhold group.
| Study group | Role | What they receive |
|---|---|---|
| Subproject A: Patients with ARDs who received the vaccine at study entry (P1) | Active comparator | Patients with ARDs who received the vaccine at study entry (P1) (n = 590). ARD patients will be randomly assigned in a 1:1 ratio, with the use of an automated Web and telephone system, to one of two subgroups: P1, patients allocated to receive vaccine right after randomization (at D0 and D42), and P2, patients allocated to receive placebo at D0 and D42. Subsequently, blindness will be broken at D84 and P2 patients will receive vaccine doses at the D84 and D126. Receives: Biological: Recombinant Herpes Zoster Vaccine (RZV) |
| Subproject A: Patients with ARDs who received the placebo at study entry (P2) | Placebo comparator | Subproject A: Patients with ARDs who received the placebo at study entry (P2) (n = 590).
ARD patients will be randomly assigned in a 1:1 ratio, with the use of an automated Web and telephone system, to one of two subgroups: P1, patients allocated to receive vaccine right after randomization (at D0 and D42), and P2, patients allocated to receive placebo at D0 and D42. Subsequently, blindness will be broken at D84 and P2 patients will receive vaccine doses at the D84 and D126. Receives: Biological: Recombinant Herpes Zoster Vaccine (RZV); Other: Placebo |
| Subproject A: Control group of non-immunosuppressed individuals (CG) | Active comparator | Subproject A: Control group of non-immunosuppressed individuals (CG) (n = 393). The control group of non-immunosuppressed individuals (CG) (≥50 years old) will be invited to receive the vaccine at study entry (3 patients:1 control). Receives: Biological: Recombinant Herpes Zoster Vaccine (RZV) |
| Subproject B: MTX-withhold | Active comparator | Subproject B: MTX-withhold (n = 101). Patients using MTX at a stable dose for at least 12 weeks, prednisone maximum dose of 5 mg/day, in association or not with other drugs except rituximab, to be randomized into two arms: one that will withhold MTX for 2 weeks after each vaccine dose (MTX-withhold) and other that will maintain stable therapy (MTX-maintain). Receives: Biological: Recombinant Herpes Zoster Vaccine (RZV); Other: MTX Discontinuation |
| Subproject B: MTX-maintain | Active comparator | Subproject B: MTX-maintain (n = 101). Patients using MTX at a stable dose for at least 12 weeks, prednisone maximum dose of 5 mg/day, in association or not with other drugs except rituximab, to be randomized into two arms: one that will withhold MTX for 2 weeks after each vaccine dose (MTX-withhold) and other that will maintain stable therapy (MTX-maintain). Receives: Biological: Recombinant Herpes Zoster Vaccine (RZV); Other: MTX maintain |
| Subproject B: MMF-withhold | Active comparator | Subproject B: MMF-withhold (n = 115). Patients with ARDs using MMF at a stable dose for at least 12 weeks, prednisone maximum dose of 7.5 mg/day, not associated with other immunosuppressive therapy, will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MMF for one week after each vaccine dose (MMF-withhold) and other that will maintain stable therapy (MMF-maintain). Receives: Biological: Recombinant Herpes Zoster Vaccine (RZV); Other: MMF Discontinuation |
| Subproject B: MMF-maintain | Active comparator | Subproject B: MMF-maintain (n = 115). Patients with ARDs using MMF at a stable dose for at least 12 weeks, prednisone maximum dose of 7.5 mg/day, not associated with other immunosuppressive therapy, will be consecutively evaluated at outpatient clinics regarding disease activity. Those considered to be at stable disease (at remission or low disease activity according to specific standardized disease activity indexes) will be randomized (1:1) into two arms: one that will withhold MMF for one week after each vaccine dose (MMF-withhold) and other that will maintain stable therapy (MMF-maintain). Receives: Biological: Recombinant Herpes Zoster Vaccine (RZV); Other: MMF maintain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subproject A: Disease safety (flare) in ARD patients immunized with RZV in comparison to non-vaccinated ARD patients (placebo group)
Flare will be defined as a new flare or worsening of previous disease activity according to established scores for each ARD or the change of therapy. Disease activity will be evaluated in ARD patients according to specific standardized disease activity indexes: RA (DAS28 - Disease Activity Score 28, RA-CDAI - Rheumatoid Arthritis Clinical Disease Activity Index), SLE (SLEDAI2K - Systemic Lupus Erythematosus Disease Activity Index 2000), pSS (ESSDAI- EULAR Sjögren's Syndrome Disease Activity Index), IIM (MMT - Manual Muscle Test), AxS (ASDAS - Ankylosing Spondylitis Disease Activity Score), and vasculitis (Birmingham Vasculitis Activity Score).
Measured: Six months
Subproject B: Effect of MTX discontinuation on immunogenicity in comparison to MTX maintenance
Humoral immunogenicity will be assessed through serum anti-gE antibody concentrations analysis (ELISA) of blood samples collected from participants at pre-vaccination, 6 weeks, and one-year after the second dose of RZV.
The frequencies of gE-specific CD4[2+] T cells (CD4+ T-cells expressing at least 2 activation markers of the 4 markers assessed: interferon-γ, interleukin 2, tumor necrosis factor-α, and CD40 ligand) will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of total research participants).
Measured: One year
Subproject B: Effect of MMF discontinuation on immunogenicity in comparison to MMF maintenance
Humoral immunogenicity will be assessed through serum anti-gE antibody concentrations analysis (ELISA) of blood samples collected from participants at pre-vaccination, 6 weeks, and one-year after the second dose of RZV.
The frequencies of gE-specific CD4[2+] T cells (CD4+ T-cells expressing at least 2 activation markers of the 4 markers assessed: interferon-γ, interleukin 2, tumor necrosis factor-α, and CD40 ligand) will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of total research participants).
Measured: One year
Secondary outcomes (2)
Subproject A: Incidence of vaccine adverse events [safety and tolerability] in ARD patients immunized with RZV in comparison to non-vaccinated ARD patients (placebo group) and non-immunosupressed controls (control group)
A standardized diary card of AEs for recording of solicited local and systemic manifestations will be systematically provided to all patients and healthy controls collected for 7 days post each vaccination. Unsolicited AEs will be recorded within 6 weeks post each vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) [potential immune mediated disorder (pIMDs)] will be evaluated throughout the entire study duration.
Measured: Eighteen months
Subproject A: Humoral immunogenicity of the RZV in ARD patients in comparison to non-immunosupressed control group
Humoral immunogenicity will be assessed through serum anti-gE antibody concentrations analysis (ELISA) of blood samples collected from participants at pre-vaccination, 6 weeks, and one-year after the second dose of RZV.
The frequencies of gE-specific CD4[2+] T cells (CD4+ T-cells expressing at least 2 activation markers of the 4 markers assessed: interferon-γ, interleukin 2, tumor necrosis factor-α, and CD40 ligand) will be measured after in vitro stimulation with a pool of peptides covering the gE ectodomain, by intracellular cytokine staining and detection by flow cytometry, in a convenience sample (20% of total research participants).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start23 May 2023
- Primary completion1 Dec 2025
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subproject A: Randomized prospective study of adult patients with ARDs who will receive two intramuscular doses of RZV 6 weeks apart or placebo. Subproject B: Specific studies will evaluate the effect of drug withdrawal (MTX and MMF) after vaccination in increasing the immune response in patients with ARDs with controlled baseline disease. Randomization of patients with ARDs with well-controlled disease selected for the MTX discontinuation protocol will divide them into two groups: MTX-suspension, in which MTX will be suspended for 2 weeks after each vaccine dose, and another group that will maintain stable therapy (MTX-maintenance), with assessments of immunogenicity and disease activity. The same applies to patients undergoing the MMF discontinuation protocol (but the MMF suspension time will be one week after each vaccine dose).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,005 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879419
- Sponsor's protocol ID
- 67374823.0.0000.0068
- Acronym
- RZVRheum
- Status last verified
- Apr 2026
- First submitted
- 2 May 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abhishek A, Boyton RJ, Peckham N, McKnight A, Coates LC, Bluett J, Barber V, Cureton L, Francis A, Appelbe D, Eldridge L, Julier P, Valdes AM, Brooks T, Rombach I, Altmann DM, Nguyen-Van-Tam JS, Williams HC, Cook JA; VROOM study investigators. Effect of a 2-week interruption in methotrexate treatment versus continued treatment on COVID-19 booster vaccine immunity in adults with inflammatory conditions (VROOM study): a randomised, open label, superiority trial. Lancet Respir Med. 2022 Sep;10(9):840-850. doi: 10.1016/S2213-2600(22)00186-2. Epub 2022 Jun 27.
PubMed 35772416Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
PubMed 20872595Anderson JK, Zimmerman L, Caplan L, Michaud K. Measures of rheumatoid arthritis disease activity: Patient (PtGA) and Provider (PrGA) Global Assessment of Disease Activity, Disease Activity Score (DAS) and Disease Activity Score with 28-Joint Counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Patient Activity Score (PAS) and Patient Activity Score-II (PASII), Routine Assessment of Patient Index Data (RAPID), Rheumatoid Arthritis Disease Activity Index (RADAI) and Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), Chronic Arthritis Systemic Index (CASI), Patient-Based Disease Activity Score With ESR (PDAS1) and Patient-Based Disease Activity Score without ESR (PDAS2), and Mean Overall Index for Rheumatoid Arthritis (MOI-RA). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S14-36. doi: 10.1002/acr.20621. No abstract available.
PubMed 22588741Bastidas A, de la Serna J, El Idrissi M, Oostvogels L, Quittet P, Lopez-Jimenez J, Vural F, Pohlreich D, Zuckerman T, Issa NC, Gaidano G, Lee JJ, Abhyankar S, Solano C, Perez de Oteyza J, Satlin MJ, Schwartz S, Campins M, Rocci A, Vallejo Llamas C, Lee DG, Tan SM, Johnston AM, Grigg A, Boeckh MJ, Campora L, Lopez-Fauqued M, Heineman TC, Stadtmauer EA, Sullivan KM; ZOE-HSCT Study Group Collaborators. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):123-133. doi: 10.1001/jama.2019.9053.
PubMed 31287523Berkowitz EM, Moyle G, Stellbrink HJ, Schurmann D, Kegg S, Stoll M, El Idrissi M, Oostvogels L, Heineman TC; Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 2015 Apr 15;211(8):1279-87. doi: 10.1093/infdis/jiu606. Epub 2014 Nov 3.
PubMed 25371534Braun-Moscovici Y, Kaplan M, Braun M, Markovits D, Giryes S, Toledano K, Tavor Y, Dolnikov K, Balbir-Gurman A. Disease activity and humoral response in patients with inflammatory rheumatic diseases after two doses of the Pfizer mRNA vaccine against SARS-CoV-2. Ann Rheum Dis. 2021 Oct;80(10):1317-1321. doi: 10.1136/annrheumdis-2021-220503. Epub 2021 Jun 18.
PubMed 34144967Cunningham AL, Heineman TC, Lal H, Godeaux O, Chlibek R, Hwang SJ, McElhaney JE, Vesikari T, Andrews C, Choi WS, Esen M, Ikematsu H, Choma MK, Pauksens K, Ravault S, Salaun B, Schwarz TF, Smetana J, Abeele CV, Van den Steen P, Vastiau I, Weckx LY, Levin MJ; ZOE-50/70 Study Group. Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.
PubMed 29529222Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macias G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, Lopez-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6.
PubMed 31399377Furer V, Eviatar T, Zisman D, Peleg H, Paran D, Levartovsky D, Zisapel M, Elalouf O, Kaufman I, Meidan R, Broyde A, Polachek A, Wollman J, Litinsky I, Meridor K, Nochomovitz H, Silberman A, Rosenberg D, Feld J, Haddad A, Gazzit T, Elias M, Higazi N, Kharouf F, Shefer G, Sharon O, Pel S, Nevo S, Elkayam O. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study. Ann Rheum Dis. 2021 Oct;80(10):1330-1338. doi: 10.1136/annrheumdis-2021-220647. Epub 2021 Jun 14.
PubMed 34127481Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
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