Symptoms and General Pathology

All Conditions

Infections

Musculoskeletal Diseases

Wounds and Injuries

Nervous System Diseases

Necrosis

Spondylitis

Spondylarthritis

Enthesopathy

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Arthritis

Joint Diseases

Tendinopathy

Muscular Diseases

Tendon Injuries

Anti-Inflammatory Agents

All Drugs and Chemicals

Tumor Necrosis Factor Inhibitors

Adrenergic alpha-Antagonists

Spondyloarthritis patients who was initiated TNF alfa blocker

TNF inhibitors are widely used in patients with spondyloarthritis

TNF Inhibitor

Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown that clinical and ultrasonographic enthesitis may improve as well as disease activity, quality of life and acute phase reactants. In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.

All patients were evaluated by the researcher who had a 10-year experience of musculoskeletal ultrasonography and is blind to clinical evaluation.

Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis

Clinical and Ultrasonographic Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Patients With Spondyloarthritis

Madrid Sonographic Enthesitis Index was used to screen etheseal sites

Bath Ankylosing Spondylitis Disease Activity Index was used

Ankylosing Spondylitis Disease Activity Score was used

Ankylosing Spondylitis Quality of Life was used

Bath Ankylosing Spondylitis Functionality Index was used

Gunay ER

Medical Doctor

Skin and Connective Tissue Diseases

Immune System Diseases

Neoplasms

Mouth and Tooth Diseases

Eye Diseases

Heart and Blood Diseases

Rare Diseases

Syndrome

Scleroderma, Systemic

Scleroderma, Diffuse

Arthritis, Rheumatoid

Mastocytosis

Sjogren's Syndrome

Arthritis, Psoriatic

Lupus Erythematosus, Systemic

Myositis

Vasculitis

Antiphospholipid Syndrome

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Spondylarthropathies

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Lacrimal Apparatus Diseases

Vascular Diseases

Disease Attributes

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Mast Cell Activation Disorders

Neuromuscular Diseases

Systemic Scleroderma

Idiopathic Inflammatory Myopathy

Spondylarthropathy

Nathalie Costedoat-Chalumeau, PhD

Adèle Bellino

nathalie Costedoat-Chalumeau, PhD

Rare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care.

Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child.

For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life.

Pregnancy and Medically Assisted Conception in Rare Diseases

Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases

It's a composite outcome . A pregnancy with no severe maternal complication (by the Epimoms\* definition), live birth after 35 weeks' gestation, a birth weight \>10th percentile of the general population and no infections (maternal and infant) during pregnancy and first year of follow up, respectively

About the organisation of care (analysis of the effect on outcome of the number of ultrasound examinations and clinician visits, and the systematic planning of delivery)

Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).

Within an existing collection with (1) samples taken during the first trimester of pregnancy to analyse markers that might predict subsequent obstetric complications (cytokines, growth factors, enzymes) (2) with cord blood samples (which will, in particular, enable immunological and pharmacological analyses).

SNFMI

CRAT

Assistance Publique - Hôpitaux de Paris

Axial Spondyloarthritis

Ankylosis

Antirheumatic Agents

Analgesics

Gastrointestinal Agents

Etanercept

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Immunosuppressive Agents

Immunologic Factors

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week, Subcutaneous injection

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injectio, 25mg per week, Subcutaneous injection

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week

50mg Yisaipu

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week

25mg etanercept

The injection method and frequency of placebo is the same as the other arms.

Placebo

Jieruo Gu, Professor

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection (Yisaipu®) in the treatment of active axial spondyloarthritis(SpA). The primary purpose is to assess the different situations in maintaining treatment programme in SpA patients with controlled inflammation by Yisaipu®. And the second purpose is to assess the eficacy and safety of Yisaipu® in axial SpAs. The trial will include 150 patients with stable NSAIDs therapy, and at the first stage they will receive 24-week full-dose of Yisaipu®. Then at the second stage the patients who achieve low disease activity (LDA, ASDAS\<2.1) at 24th week will be randomizedly divided into three group: full-dose of Yisaipu® group, half-dose of Yisaipu® group and placebo group. And the blind stage will last for 48 weeks. Patients who complete the 72-week therapy or achieve disease-flare criteria during the blind stage would finish the study.

This randomised controlled trial enrolled adult patients aged 18 years or older diagnosed with non-radiographic axial spondyloarthritis at 3 centres in China. Patients had to fulfil ASAS axial spondyloarthritis criteria but could not fulfil the modified New York radiologic criterion for ankylosing spondylitis,and had to have objective evidence of active inflammation or chronic structral change，such as bone erosion or fat metaplasia in the sacroiliac joints on MRI at screening. Active disease activity was defined as a disease activity score in ASDAS-CRP ≥2.1,or Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] ≥4 on a numerical rating scale of 0-10, and an inadequate response to more than one non-steroidal anti-inflammatory drugs (NSAIDs) for 4 weeks at least, intolerance to NSAIDs, or contraindication for NSAIDs. No change in NSAIDs dose was required from 2 weeks before screening to the end of the study. Dose stability or discontinuation was required for 4 weeks before baseline for concomitant DMARDs or corticosteroids (prednisone or equivalent at a dose of less than 10 mg/day). Chinese herbal medicine, physical therapy, or live (attenuated) vaccine, or intravenous immunoglobulin IgG, was required for discontinuation and wash period for at least 4 weeks. Patients were excluded if they had previously taken or were taking biologic treatment, any biologic Dmards such as IL-6 or CD-20 inhibitors. Patients with latent tuberculosis infection were included only when local guidelines were followed for prophylactic treatment and if treatment was initiated before Yisaipu.

All patients provided written informed consent, and the study protocol was approved by an institutional review board or independent ethics committee at each study site. The study was conducted in accordance with applicable regulations and the ethical principles of Good Clinical Practice as defined by the International Conference on Harmonisation (ICH) and the Declaration of Helsinki.

A randomized envelope was used to enrol all patients at the baseline visit and to randomly assign qualifying patients in a 1:1:1 ratio to receive either blinded Yisaipu 50 mg subcutaneously every week or 25 mg subcutaneously every week or matching placebo at week 24. All study personnel, including the sponsor (with the exception of the Sanshengguojian drug supply management team), investigator, and study site personnel, and the patient remained blinded to treatment throughout the double-blinded period from week 24 through week 72 of the study. Investigational products were provided to maintain blinding.

In the initial open-label period, enrolled patients were given subcutaneous injections of 50 mg Yisaipu every week for 36 weeks. Participants were given the dose of NSAIDs they had been receiving at screening; a dose decrease or discontinuation was allowed when the patients were intolerance to NSAIDs, or contraindication for NSAIDs. Patients who achieved clinical remission, defined as achieving ASDAS inactive or moderate disease (ASDAS score \<2.1) at weeks 24, were randomly assigned to receive either blinded 50mg Yisaipu (continuation arm), 25mg Yisaipu(reduction arm) or matching placebo (withdrawal arm) for 48 weeks during the double-blind period, for a total of 72 weeks of treatment.

During the double-blind period, patients who experienced a flare (defined as an increase in BASDAI ≥2 points compare to the BASDAI score when randomization) were allocate to termination of this trial.

Treatment of Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein

Treatment of Active Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection: a Randomized, Double-blind, Multicentral Clinical Trial to Investigate the Efficacy and Safety of Yisaipu®

in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period

The unabbreviated scale title is VAS from 0 to 100mm. 100 mm mean the most severe pain

Sun Yat-sen University

Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Chelating Agents

Certolizumab Pegol

Immunoglobulin Fab Fragments

Sodium Pertechnetate Tc 99m

In total there will be 20 patients included: 5 patients with active rheumatoid arthritis, 5 patients with active early axial spondyloarthritis, 5 patients with active early peripheral spondyloarthritis and 5 patients with active ankylosing spondylitis.

Patients will be treated with prefilled syringes containing each 200 mg/ml Cimzia® every 2 weeks which will be administered subcutaneously (The first 3 injections, a dosage of 400mg Cimzia® subcutaneously will be administered).

administration of Cimzia®

All 20 patients will undergo an immunoscintigraphy with radiolabeled Cimzia®. Certolizumab pegol (Cimzia®) is an engineered humanized monoclonal antibody Fab' fragment with specificity for human TNF-α, manufactured in E. coli. The antibody fragment is subsequently purified and conjugated with high molecular weight polyethylene glycol (PEG) (40kDa). Lyophilized Cimzia® will be conjugated with S-HYNIC (a bifunctional chelator). The conjugate will be radiolabeled with Tc-99m by adding 0.1 mg Tricine, 0.01 mg SnSO4 and 750 MBq Tc-99m pertechnetate. A dose of 750 MBq Tc-99m Cimzia® will be injected intravenously.

Immunoscintigraphy with radiolabeled Cimzia®.

Filip Van den Bosch, MD

In this open-label monocentric explorative pilot trial the objective is to show the biodistribution of TNFα by administration of radiolabeled anti-TNFα in patients with active rheumatoid arthritis and spondylarthropathy. The anti-TNFα used in this trial is certolizumab pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for TNFα. Certolizumab pegol will be radiolabeled with 99mTechnetium. The aim of this study is to show the TNFα triggered inflammation process in the inflamed joints, especially in patients who have very early joint damage where currently other imaging methods such as X-rays are not sensitive enough for detection.

Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFα in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis

After performing the immunoscintigraphy there will be evaluation of the correlation between visualised joint inflammation on the one hand seen by clinical examination , on MRI and on ultrasound and on the other hand seen on the immunoscintigraphy.

All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.

A secondary endpoint will be the changes in the tender and swollen joint count (76/78 joint count) at week 26 in comparison with baseline.

This will be done by using the different scoring systems with inclusion of all relevant entheses.

patient global assessment of disease activity, patient pain assessment (peripheral and axial pain), physician global assessment of disease activity, BASDAI and DAS28.

UCB Pharma SA

University Hospital, Ghent

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Papillomavirus Infections

Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up.

Cervical smear will be obtained using an Ayre spatula and a cervical brush (Cervex-Brush®). HPV test will be performed using the CLART® HPV2 kit (Genomica).This kit enables the detection of 35 genotypes: HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43,44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 82, 83, 84, 85 et 89.

Cervical smear

Pregnancy test

Sexual activity questionnary

Fabienne COURY-LUCAS, MD

Gery Lamblin, MD

Gery Lamblin

Emmanuelle VIGNOT, MD

Emmanuelle Vignot, MD

Fabienne Coury-lucas, MD

Muriel PIPERNO, MD

Jean-Paul LARBRE, MD

Nathalie HOEN, MD

Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are the two most common chronic inflammatory rheumatism, with a prevalence in the French population of 0.3% and 0.4%, according to the criteria European League Against Rheumatism / American College of Rheumatology (EULAR / ACR) 2010 and Assessemnt of SpondyloArthritis International Society (ASAS) 2009 respectively. In patients whose pathology is resistant to first-line treatment, such as methotrexate for rheumatoid arthritis and peripheral spondyloarthritis, or non-steroidal anti-inflammatory drugs for axial spondyloarthritis, the treatment is based on biotherapies, such as anti-inflammatory drugs. -TNF, to obtain effective control of the disease and prevent joint damage.

Human papillomavirus (HPV) infection, the leading risk factor for cervical carcinoma, is the most common sexually transmitted infection (STI) with a particularly high prevalence among young women.

In addition, anti-TNF, used in the treatment of RA and SpA, and anti-IL6 receptor, used in that of RA, could have opposite effects on HPV-dependent oncogenesis.

Thus, patients with RA or SpA may have a higher risk than the general population of progression to cervical cytological abnormalities. Evaluation of the chronic carriage of HPV would then be a useful tool in the management of these patients.

Papillomavirus Load in Rheumatic Inflammatory Diseases

Papillomavirus chronic load is defined as a positive HPV test at the end of the study combined with at least 3 positive HPV tests during the 24 months follow-up.

Number of patients with a positive HPV test at enrollment

Number of patients with a negative HPV test at enrollment and having at least one positive HPV test during the 24 months follow-up

Number of patients with a positive HPV test at enrollment and having a negative HPV test at the end of the study.

Number of patients with low-grade and high-grade cytological abnormalities during follow-up among those who had normal cytology at enrollment.

Number of patients ,with normal cytology at enrollment, whose cervical smear indicates a regression in cytological abnormalities or a persistence of cytological abnormalities or a development of abnormalities into cervical cancer or dysplasia, during the 24 months follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis	NCT04953871	Spondyloarthrit... Enthesitis Anti-Tumor Necr...	TNF Inhibitor	18 Years - 65 Years	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Pregnancy and Medically Assisted Conception in Rare Diseases	NCT02450396	Rheumatoid Arth... Spondyloarthrit... Psoriatic Arthr... Systemic Lupus ... Antiphospholipi... Sjogren Syndrom... Scleroderma Myositis Vasculitis Mastocytosis Various Autoimm...		-	Assistance Publique - Hôpitaux de Paris
Treatment of Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein	NCT02364479	Spondyloarthrit...	50mg Yisaipu 25mg etanercept Placebo	18 Years -	Sun Yat-sen University
Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFα in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis	NCT01590966	Axial and Perip... Rheumatoid Arth...	administration ... Immunoscintigra...	18 Years - 70 Years	University Hospital, Ghent
Papillomavirus Load in Rheumatic Inflammatory Diseases	NCT03713736	Spondyloarthrit... Rhumatoid Arthi...	Cervical smear Pregnancy test Sexual activity...	18 Years - 65 Years	Hospices Civils de Lyon
Papillomavirus Load in Rheumatic Inflammatory Diseases	NCT03713736	Spondyloarthrit... Rhumatoid Arthi...	Cervical smear Pregnancy test Sexual activity...	18 Years - 65 Years	Hospices Civils de Lyon
Pregnancy and Medically Assisted Conception in Rare Diseases	NCT02450396	Rheumatoid Arth... Spondyloarthrit... Psoriatic Arthr... Systemic Lupus ... Antiphospholipi... Sjogren Syndrom... Scleroderma Myositis Vasculitis Mastocytosis Various Autoimm...		-	Assistance Publique - Hôpitaux de Paris

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