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Article ; Online: Vaccination against influenza and pneumococus in patients with rheumatoid arthritis.

Tobar-Marcillo, Marco / Guerrero-Solís, Carlos / Pool-Valda, Guillermo Osmar / Irazoque-Palazuelos, Fedra / Muñoz-López, Sandra

Reumatologia clinica

2022

Abstract: Background: Vaccination against pathogens such as influenza or pneumococcus is widely recommended for patients with rheumatoid arthritis; the prevalence of adherence to these vaccination programmes in Mexico is not known.: Methods: A cross-sectional ... ...

Abstract	Background: Vaccination against pathogens such as influenza or pneumococcus is widely recommended for patients with rheumatoid arthritis; the prevalence of adherence to these vaccination programmes in Mexico is not known. Methods: A cross-sectional descriptive study was carried out, through the application of a survey to adult patients with a diagnosis of rheumatoid arthritis treated in a tertiary hospital in Mexico City. Results: 227 patients were included, vaccination against influenza was found in 31.3% and against pneumococcus in 17.6% of patients, the main reasons for non-compliance with the vaccination schedule were related to ignorance and the recommendation by doctors not to do so. Conclusions: Compliance with the recommended vaccination schedules in the studied population is lower than those reported in other populations. The most important interventions to improve coverage should be aimed at educating both patients and medical personnel.
Language	English
Publishing date	2022-05-12
Publishing country	Spain
Document type	Case Reports
ISSN	2173-5743
ISSN (online)	2173-5743
DOI	10.1016/j.reumae.2021.11.003
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Article ; Online: Phase 2 Trial of Iberdomide in Systemic Lupus Erythematosus.

Merrill, Joan T / Werth, Victoria P / Furie, Richard / van Vollenhoven, Ronald / Dörner, Thomas / Petronijevic, Milan / Velasco, Jorge / Majdan, Maria / Irazoque-Palazuelos, Fedra / Weiswasser, Michael / Korish, Shimon / Ye, Ying / Gaudy, Allison / Schafer, Peter H / Liu, Zhaohui / Agafonova, Nataliya / Delev, Nikolay

The New England journal of medicine

2022 Volume 386, Issue 11, Page(s) 1034–1045

Abstract: Background: Iberdomide, a cereblon modulator promoting degradation of the transcription factors Ikaros and Aiolos, which affect leukocyte development and autoimmunity, is being evaluated for the treatment of systemic lupus erythematosus (SLE).: ... ...

Abstract	Background: Iberdomide, a cereblon modulator promoting degradation of the transcription factors Ikaros and Aiolos, which affect leukocyte development and autoimmunity, is being evaluated for the treatment of systemic lupus erythematosus (SLE). Methods: In this phase 2 trial, we randomly assigned patients in a 2:2:1:2 ratio to receive oral iberdomide (at a dose of 0.45, 0.30, or 0.15 mg) or placebo once daily for 24 weeks, in addition to standard medications. The primary end point at week 24 was a response on the SLE Responder Index (SRI-4), which was defined as a reduction of at least 4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 score (a 24-item weighted score of lupus activity that ranges from 0 to 105, with higher scores indicating greater disease activity), no new disease activity as measured on the British Isles Lupus Assessment Group 2004 index, and no increase of 0.3 points or more in the Physician's Global Assessment score (on a visual-analogue scale ranging from 0 [no disease activity] to 3 [maximal disease]). Results: A total of 288 patients received the assigned intervention: 81 received iberdomide at a dose of 0.45 mg, 82 received iberdomide at a dose of 0.30 mg, 42 received iberdomide at a dose of 0.15 mg, and 83 received placebo. At week 24, the percentages of patients with an SRI-4 response were 54% in the iberdomide 0.45-mg group, 40% in the iberdomide 0.30-mg group, 48% in the iberdomide 0.15-mg group, and 35% in the placebo group (adjusted difference between the iberdomide 0.45-mg group and the placebo group, 19.4 percentage points; 95% confidence interval, 4.1 to 33.4; P = 0.01), with no significant differences between the groups that received the lower doses of iberdomide and the group that received placebo. Iberdomide-associated adverse events included urinary tract and upper respiratory tract infections and neutropenia. Conclusions: In this 24-week, phase 2 trial involving patients with SLE, iberdomide at a dose of 0.45 mg resulted in a higher percentage of patients with an SRI-4 response than did placebo. Data from larger, longer trials are needed to determine the efficacy and safety of iberdomide in SLE. (Funded by Bristol Myers Squibb; ClinicalTrials.gov number, NCT03161483; EudraCT number, 2016-004574-17.).
MeSH term(s)	Adaptor Proteins, Signal Transducing/agonists ; Adult ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Humans ; Ikaros Transcription Factor/metabolism ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Erythematosus, Systemic/ethnology ; Male ; Middle Aged ; Morpholines/administration & dosage ; Morpholines/pharmacology ; Morpholines/therapeutic use ; Phthalimides/administration & dosage ; Phthalimides/pharmacology ; Phthalimides/therapeutic use ; Piperidones/administration & dosage ; Piperidones/pharmacology ; Piperidones/therapeutic use ; Severity of Illness Index ; Ubiquitin-Protein Ligases/metabolism
Chemical Substances	Adaptor Proteins, Signal Transducing ; CRBN protein, human ; IKZF3 protein, human ; Morpholines ; Phthalimides ; Piperidones ; Ikaros Transcription Factor (148971-36-2) ; iberdomide (8V66F27X44) ; Ubiquitin-Protein Ligases (EC 2.3.2.27)
Language	English
Publishing date	2022-04-06
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2106535
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Article ; Online: Biological impact of iberdomide in patients with active systemic lupus erythematosus.

Annals of the rheumatic diseases

2022

Abstract: Objectives: Iberdomide is a high-affinity cereblon ligand that promotes proteasomal degradation of transcription factors Ikaros (: Methods: Adults with autoantibody-positive SLE were randomised to placebo (n=83) or once daily iberdomide 0.15 mg (n=42) ...

Abstract	Objectives: Iberdomide is a high-affinity cereblon ligand that promotes proteasomal degradation of transcription factors Ikaros ( Methods: Adults with autoantibody-positive SLE were randomised to placebo (n=83) or once daily iberdomide 0.15 mg (n=42), 0.3 mg (n=82) or 0.45 mg (n=81). Pharmacodynamic changes in whole blood leucocytes were measured by flow cytometry, regulatory T cells (Tregs) by epigenetic assay, plasma cytokines by ultrasensitive cytokine assay and gene expression by Modular Immune Profiling. Results: Iberdomide exhibited linear pharmacokinetics and dose-dependently modulated leucocytes and cytokines. Compared with placebo at week 24, iberdomide 0.45 mg significantly (p<0.001) reduced B cells, including those expressing CD268 (TNFRSF13C) (-58.3%), and plasmacytoid dendritic cells (-73.9%), and increased Tregs (+104.9%) and interleukin 2 (IL-2) (+144.1%). Clinical efficacy was previously reported in patients with high Conclusion: Iberdomide significantly reduced activity of type I IFN and B cell pathways, and increased IL-2 and Tregs, suggesting a selective rebalancing of immune abnormalities in SLE. Clinical efficacy corresponded to reduction of the type I IFN gene signature. Trial registration number: NCT03161483.
Language	English
Publishing date	2022-04-27
Publishing country	England
Document type	Journal Article
ZDB-ID	7090-7
ISSN	1468-2060 ; 0003-4967
ISSN (online)	1468-2060
ISSN	0003-4967
DOI	10.1136/annrheumdis-2022-222212
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Article ; Online: Epidemiología, etiología y clasificación.

Irazoque-Palazuelos, Fedra / Barragán-Navarro, Yaneth

Reumatologia clinica

2009 Volume 5 Suppl 3, Page(s) 2–5

Abstract: Idiopathic inflammatory myopathies are a group of heterogeneous striated muscle acquired autoimmune diseases, characterized by progressive symmetrical muscle weakness, elevated serum levels of muscle enzymes, electromyographic abnormalities and ... ...

Title translation	Epidemiology, etiology and classification.
Abstract	Idiopathic inflammatory myopathies are a group of heterogeneous striated muscle acquired autoimmune diseases, characterized by progressive symmetrical muscle weakness, elevated serum levels of muscle enzymes, electromyographic abnormalities and inflammatory infiltrates on muscle biopsy. This group of diseases comprises polymyositis, dermatomyositis and inclusion-body myositis. They are considered rare autoimmune diseases, with an overall incidence range of 2 to 10 new cases per million persons at risk per year, with differences in distribution according to age, gender and race. Their etiology is largely unknown, but it likely involves both genetic and environmental factors that contribute to autoimmune disorders, with striated muscle as a common target.
Language	Spanish
Publishing date	2009-11
Publishing country	Spain
Document type	English Abstract ; Journal Article
ZDB-ID	2477196-X
ISSN	1885-1398 ; 1699-258X
ISSN (online)	1885-1398
ISSN	1699-258X
DOI	10.1016/j.reuma.2009.09.007
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Article ; Online: Methotrexate withdrawal in patients with rheumatoid arthritis who achieve low disease activity with tofacitinib modified-release 11 mg once daily plus methotrexate (ORAL Shift): a randomised, phase 3b/4, non-inferiority trial.

Cohen, Stanley B / Pope, Janet / Haraoui, Boulos / Irazoque-Palazuelos, Fedra / Korkosz, Mariusz / Diehl, Annette / Rivas, Jose L / Lukic, Tatjana / Liu, Shixue / Stockert, Lori / Iikuni, Noriko / Keystone, Edward C

The Lancet. Rheumatology

2019 Volume 1, Issue 1, Page(s) e23–e34

Abstract: Background: Tofacitinib is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis. We assessed the efficacy and safety of tofacitinib after methotrexate withdrawal in patients who achieved low disease activity (LDA) with ... ...

Abstract	Background: Tofacitinib is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis. We assessed the efficacy and safety of tofacitinib after methotrexate withdrawal in patients who achieved low disease activity (LDA) with tofacitinib in combination with methotrexate. Methods: ORAL Shift was a phase 3b/4 non-inferiority trial in patients aged at least 18 years with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate done in 109 centres across 16 countries. After 24 weeks of open-label tofacitinib modified-release 11 mg once daily plus methotrexate, patients who achieved LDA (clinical disease activity index [CDAI] ≤10) were randomly assigned 1:1 via an automated web-based response system to receive tofacitinib plus placebo (tofacitinib monotherapy; ie, masked methotrexate withdrawal) or continue tofacitinib plus methotrexate for 24 weeks in a double-blind manner. The primary endpoint was the least squares mean change from week 24 to week 48 in disease activity score in 28 joints with four variables, including erythrocyte sedimentation rate (DAS28-4[ESR]). The primary analysis was done in all patients who received at least one dose of study treatment in both phases, and safety was assessed in all patients who received at least one dose of study treatment since enrolment. Non-inferiority of tofacitinib monotherapy versus tofacitinib plus methotrexate was declared if the upper bound of the 95% CI for the difference in change in DAS28-4(ESR) between treatment groups was less than 0·6. Safety was assessed in both phases. The trial is registered with ClinicalTrials.gov, NCT02831855, and is complete. Findings: Between Sept 1, 2016, and Nov 1, 2017, 694 patients were enrolled in the open-label phase and 623 received study treatment for 24 weeks. 533 achieved CDAI-defined LDA and were randomly assigned into the double-blind phase (267 in the tofacitinib monotherapy group and 266 in the tofacitinib plus methotrexate group). Three participants in the monotherapy group did not start treatment so were not included in the primary analysis. Non-inferiority was demonstrated (difference 0·30 [95% CI 0·12-0·48]). 107 (41%) of 264 patients in the tofacitinib monotherapy group and 109 (41%) of 266 in the tofacitinib plus methotrexate group had adverse events; five patients from each group discontinued because of adverse events; two patients died in the tofacitinib plus methotrexate group. No new safety findings were reported up to 48 weeks. Interpretation: Patients with rheumatoid arthritis who achieve LDA with a combination of tofacitinib plus methotrexate may consider withdrawing methotrexate without significant worsening of disease activity or unexpected safety issues. Funding: Pfizer.
Language	English
Publishing date	2019-08-06
Publishing country	England
Document type	Journal Article
ISSN	2665-9913
ISSN (online)	2665-9913
DOI	10.1016/S2665-9913(19)30005-0
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Article ; Online: Efficacy of tocilizumab in refractory adult-onset Still's disease; report of 2 cases.

Andrade-Ortega, Lilia / Irazoque-Palazuelos, Fedra / Muñoz-López, Sandra / Rosales-Don Pablo, Victor M

Reumatologia clinica

2014 Volume 10, Issue 3, Page(s) 199–200

MeSH term(s)	Antibodies, Monoclonal, Humanized/therapeutic use ; Female ; Humans ; Middle Aged ; Still's Disease, Adult-Onset/drug therapy ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal, Humanized ; tocilizumab (I031V2H011)
Language	Spanish
Publishing date	2014-05
Publishing country	Spain
Document type	Case Reports ; Letter
ZDB-ID	2477196-X
ISSN	1885-1398 ; 1699-258X
ISSN (online)	1885-1398
ISSN	1699-258X
DOI	10.1016/j.reuma.2013.05.004
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Article ; Online: Efficacy and tolerability of rituximab in patients with rhupus.

Andrade-Ortega, Lilia / Irazoque-Palazuelos, Fedra / Muñóz-López, Sandra / Rosales-Don Pablo, Victor Manuel

Reumatologia clinica

2013 Volume 9, Issue 4, Page(s) 201–205

Abstract: Rhupus in an infrequent disease in which an overlap between lupus eritematosus and rheumatoid arthritis exists. Joint manifestations are prominent and treatment with non biological DMARDs is not always satisfactory, so immunosupressors and biological ... ...

Abstract	Rhupus in an infrequent disease in which an overlap between lupus eritematosus and rheumatoid arthritis exists. Joint manifestations are prominent and treatment with non biological DMARDs is not always satisfactory, so immunosupressors and biological agents have been tried. A prospective, open clinical study was done to evaluate efficacy and tolerability of rituximab in patients with Rhupus. The main objective was a change in DAS28 at 6 months and secondary objectives were a change in MEX-SLEDAI at 6 months, change in DAS28 and MEX-SLEDAI during follow up, steroid requirements and detection of adverse events. We included 9 women with a mean age of 43 years and disease duration of 10 years. A significant reduction in DAS28 was observed (from 5.73 at baseline to 3.02 at 6 months, P<.001). Improvement in DAS28 was maintained during follow up. At 6 months, 3 patients were in remission and 3 had low disease activity. MEX-SLEDAI diminished from 5 points at baseline to 1.22 at 6 months (P<.001). There was a negative correlation between clinical improvement and anti-CCP levels (r=-0,794, P=.011). Mean prednisone dose was reduced from 11.66mg/day at baseline to 0,55 and 1.11mg/day at 12 and 24 months. Treatment was well tolerated. In this study rituximab was effective not only for joint affection but also for other manifestations of the disease. We consider that this biological agent can be a good therapeutic option for patients with rhupus.
MeSH term(s)	Adult ; Antibodies, Monoclonal, Murine-Derived/adverse effects ; Antibodies, Monoclonal, Murine-Derived/therapeutic use ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/complications ; Arthritis, Rheumatoid/drug therapy ; Female ; Humans ; Lupus Erythematosus, Systemic/complications ; Lupus Erythematosus, Systemic/drug therapy ; Male ; Middle Aged ; Prospective Studies ; Rituximab
Chemical Substances	Antibodies, Monoclonal, Murine-Derived ; Antirheumatic Agents ; Rituximab (4F4X42SYQ6)
Language	Spanish
Publishing date	2013-07
Publishing country	Spain
Document type	Clinical Trial ; Journal Article
ZDB-ID	2477196-X
ISSN	1885-1398 ; 1699-258X
ISSN (online)	1885-1398
ISSN	1699-258X
DOI	10.1016/j.reuma.2012.10.010
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Article: Hematomielia en lupus eritematoso generalizado y síndrome antifosfolipídico secundario: informe de un caso.

Irazoque-Palazuelos, Fedra / Sosa-Espinosa, Patricia V / Andrade-Ortega, Lilia

Reumatologia clinica

2008 Volume 4, Issue 1, Page(s) 34–36

Abstract: Intraspinal hemorrhage is very rare and intramedullary hemorrhage, also called "hematomyelia," is the rarest form of intraspinal hemorrhage. There are few reports in medical literature. We report the case of a woman of 43 years with diagnosis of systemic ...

Title translation	Hematomyelia in systemic lupus erythematosus and secondary antiphospholipid syndrome: case report.
Abstract	Intraspinal hemorrhage is very rare and intramedullary hemorrhage, also called "hematomyelia," is the rarest form of intraspinal hemorrhage. There are few reports in medical literature. We report the case of a woman of 43 years with diagnosis of systemic lupus erythematosus and secondary antiphospholipid syndrome under anticoagulant therapy that presented hematomyelia. We describe the clinical course, the findings in the image studies and surgery, and the available information in the literature.
Language	Spanish
Publishing date	2008-01
Publishing country	Spain
Document type	English Abstract ; Journal Article
ZDB-ID	2231357-6
ISSN	1699-258X
ISSN	1699-258X
DOI	10.1016/S1699-258X(08)71793-5
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Article ; Online: Factors Associated With Mortality in Patients With Immune-Mediated Rheumatic Diseases and COVID-19 From Latin America: Data From Argentina, Mexico, and Brazil.

Isnardi, Carolina Ayelen / Alpizar-Rodriguez, Deshire / Calderaro, Débora Cerqueira / Marques, Claudia Diniz Lopes / Pons-Estel, Guillermo Javier / Xavier, Ricardo Machado / Saurit, Verónica / Pisoni, Cecilia Nora / Tissera, Yohana Soledad / D'Angelo Exeni, Maria Eugenia / Alba, Paula / Pereira, Dora / Gobbi, Carla Andrea / Gamba, Maria Julieta / Alfaro, María Agustina / Virasoro, Belén María / Colunga-Pedraza, Iris Jazmín / Irazoque-Palazuelos, Fedra / Reyes-Cordero, Greta /

Rodriguez-Reyna, Tatiana S / Veloz-Aranda, Jose Antonio / Skinner-Taylor, Cassandra Michele / Juárez-Mora, Ingrid Maribel / Silveira, Luis H / Pacheco Tena, Cesar Francisco / Xibille-Friedmann, Daniel Xavier / Ferreira, Gilda Aparecida / Kakehasi, Adriana Maria / Pinheiro, Marcelo Medeiros / Gomides, Ana Paula Monteiro / Pileggi, Gecilmara Cristina Salviato / da Mota, Licia Maria Henrique / Dos Reis-Neto, Edgard Torres / Ribeiro, Sandra Lúcia Euzébio / de Azevedo Valadares, Lilian David / Martínez-Martínez, Marco Ulises

Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases

2023 Volume 30, Issue 1, Page(s) e9–e17

Abstract: Objective: To describe characteristics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in patients with rheumatic immune-mediated inflammatory diseases (IMIDs) from Argentina, Mexico and Brazil, and to assess factors associated ...

Abstract	Objective: To describe characteristics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in patients with rheumatic immune-mediated inflammatory diseases (IMIDs) from Argentina, Mexico and Brazil, and to assess factors associated with mortality in this population. Methods: Data from 3 national registries, SAR-COVID (Argentina), CMR-COVID (Mexico), and ReumaCoV-Brasil (Brazil), were combined. Adult patients with IMIDs and SARS-CoV-2 infection were recruited. Sociodemographic data, comorbidities, IMID clinical characteristics and treatment, and SARS-CoV-2 infection presentation and outcomes were recorded. Results: A total of 4827 individuals were included: 2542 (52.7%) from SAR-COVID, 1167 (24.2%) from CMR-COVID, and 1118 (23.1%) from ReumaCoV-Brasil. Overall, 82.1% were female with a mean age of 49.7 (SD, 14.3) years; 22.7% of the patients were hospitalized, and 5.3% died because of COVID-19 (coronavirus disease 2019). Argentina and Brazil had both 4% of mortality and Mexico 9.4%. In the multivariable analysis, older age (≥60 years; odds ratio [OR], 7.4; 95% confidence interval [CI], 4.6-12.4), male sex (OR, 1.5; 95% CI, 1.1-2.1), living in Mexico (OR, 3.0; 95% CI, 2.0-4.4), comorbidity count (1 comorbidity: OR, 1.5; 95% CI, 1.0-2.1), diagnosis of connective tissue disease or vasculitis (OR, 1.8; 95% CI, 1.3-2.4), and other diseases (OR, 2.6; 95% CI, 1.6-4.1) compared with inflammatory joint disease, high disease activity (OR, 4.2; 95% CI, 2.5-7.0), and treatment with glucocorticoids (OR, 1.9; 95% CI, 1.4-2.5) or rituximab (OR, 4.2; 95% CI, 2.7-6.6) were associated with mortality. Conclusions: Mortality in patients with IMIDs was particularly high in Mexicans. Ethnic, environmental, societal factors, and different COVID-19 mitigation measures adopted have probably influenced these results.
MeSH term(s)	Adult ; Humans ; Male ; Female ; Middle Aged ; COVID-19 ; SARS-CoV-2 ; Mexico/epidemiology ; Latin America ; Argentina/epidemiology ; Brazil/epidemiology ; Rheumatic Diseases/epidemiology ; Immunomodulating Agents
Chemical Substances	Immunomodulating Agents
Language	English
Publishing date	2023-11-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	1283266-2
ISSN	1536-7355 ; 1076-1608
ISSN (online)	1536-7355
ISSN	1076-1608
DOI	10.1097/RHU.0000000000002038
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Article ; Online: Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.

Rheumatology (Oxford, England)

2019 Volume 58, Issue 12, Page(s) 2193–2202

Abstract: Objective: To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA.: Methods: Patients received 48 weeks' treatment with CT- ...

Abstract	Objective: To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA. Methods: Patients received 48 weeks' treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48-72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed. Results: At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups. Conclusion: Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety. Trail registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02149121.
MeSH term(s)	Adult ; Antibodies, Monoclonal, Murine-Derived/therapeutic use ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Biosimilar Pharmaceuticals ; Double-Blind Method ; Drug Substitution ; Europe ; Female ; Humans ; Male ; Middle Aged ; Quality of Life ; Rituximab/therapeutic use ; Treatment Outcome ; United States
Chemical Substances	Antibodies, Monoclonal, Murine-Derived ; Antirheumatic Agents ; Biosimilar Pharmaceuticals ; CT-P10 ; Rituximab (4F4X42SYQ6)
Language	English
Publishing date	2019-07-04
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1464822-2
ISSN	1462-0332 ; 1462-0324
ISSN (online)	1462-0332
ISSN	1462-0324
DOI	10.1093/rheumatology/kez152
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