Use of anti-rheumatic treatment with TNF-α inhibitor (subcutaneous injection given once or twice a week) or JAK inhibitor (per oral tablet once or twice a day)

Physical hand training 10 min twice daily while on stable treatment

Rheumatoid Arthritis

Pain

Fatigue

Cognitive Decline

Depression

Brain Diseases

Hand Rheumatism

TNF-α inhibitor OR JAK inhibitor

Hand training

Clinical Rheumatology Research Center (CRRC), Department of Rheumatology, Sahlgrenska University Hospital

Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients

Treatment of Inflammation Versus Hand Training to Prevent and Revert Neuropsychiatric Comorbidity in Patients With Rheumatoid Arthritis

Magnetic resonance imaging (MRI) of all patients brains will be performed at base-line and at follow-up visit after 6 months. Measurement of 83 anatomical regions of the brain will be performed to detect subtle changes in volume. This is performed using multiatlas propagation with enhanced registration (MAPER) and the 2017 version of the Hammersmith atlas database.
The difference in regional brain volume between study visits will be calculated.

Scoring of disease activity for all patients will be performed at base-line and at follow-up visit after 6 months. Disease Activity Score is a standardised indicator of RA disease activity calculated as a composite score of: number of tender and swollen joints (assessed by trained personnel), erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) and the patients assessment of pain on a visual analogue scale of 10 mm (VAS).
The difference in Disease activity score between study visits will be calculated.

Scoring of tender Points for all patients will be performed at base-line and at follow-up visit after 6 months. Tender points are sensitive areas on the body that elicit pain and tenderness when pressure is applied. The TP 18 protocol is a standardised measurement of number of painful/tender points out of 18 bilateral points on the body.
The difference in Tender Point score between study visits will be calculated.

Scoring of Pain VAS will be performed daily by all patients and recorded in a pain diary. Pain VAS is the patients scoring in mm of overall perceived pain on a 10 mm long visual analogue scale.
The difference in Pain VAS score between daily recordings will be calculated.

Measurement of hand joint mobility for all patients will be performed at base-line and at follow-up visit after 3 and 6 months. Hand joint mobility is clinically assessed by occupational therapist according to a standardised protocol and reported as degrees of mobility in extension/flexion and pronation/supination of the hand joint.
The difference in degrees of hand joint mobility between study visits will be calculated.

Measurement of finger joint mobility for all patients will be performed at base-line and at follow-up visit after 3 and 6 months. Finger joint mobility is clinically assessed by occupational therapist according to standardised protocol and reported as degrees of mobility in extension/flexion of each finger.
The difference in degrees of finger joint mobility between study visits will be calculated.

Measurement of hand grip strength for all patients will be performed at base-line and at follow-up visit after 3 and 6 months. Hand grip strength is clinically assessed by occupational therapist and performed using Grippit®, a standardised electronic handheld instrument used for measuring hand strength in the cylinder grip.
The patient is instructed to grip the Grippit® and squeeze it as hard as possible for 10 seconds. The instrument generates three values; the maximal value of force applied, the mean value of force applied during the 10 seconds and a final value measured during the last half a second. The values are reported in Newton (N). Both hands are examined and which of the hands that is dominant is noted.
The difference in Newton between study visits will be calculated.

Documentation of hand/finger joint deformities for all patients will be performed at base-line and at follow-up visit after 3 and 6 months. Hand and finger joint deformities is clinically assessed by occupational therapist according to standardised protocol.
Reported in text for each joint

Documentation of RA-related skeletal changes for all patients will be performed at base-line and at follow-up visit after 6 months. Radiological imaging of the hand joint will be performed using plain X-ray. The assessment of hand radiographs and scoring of possible joint damage will be performed by experienced rheumatologist.
The difference in score between study visits will be calculated.

Serum samples will be gathered from all patients at base-line and follow-up visit after 3 and 6 months. Levels of various inflammatory markers will be measured and the difference in levels between study visits will be calculated.

DASH, "Disabilities of the Arm, Shoulder and Hand", is a self-administered questionnaire regarding symptoms and ability to perform certain activities. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol.
The difference in DASH score between study visits will be calculated.

FIQ, "Fibromyalgia Impact Questionnaire", is a self-administered questionnaire regarding pain, fatigue, functional ability, quality of life etc. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol.
The difference in FIQ score between study visits will be calculated.

HADS, "Hospital Anxiety and Depression Scale", is a self-administered questionnaire regarding anxiety and depression. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol.
The difference in HADS score between study visits will be calculated.

IPAQ, "International Physical Activity Questionnaire", is a self-administered questionnaire regarding physical activity and inactivity. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol.
The difference in IPAQ score between study visits will be calculated.

HAQ, "Health Assessment Questionnaire", is a self-administered questionnaire regarding functional ability and overall health. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol.
The difference in HAQ score between study visits will be calculated.

SF-36, "Short Form Health Survey", is a self-administered questionnaire regarding overall health. The questionnaire will be filled out by all patients at base-line and at follow-up visit after 3 and 6 months and scored according to established protocol.
The difference in SF-36 score between study visits will be calculated.

Fecal sample will be gathered from all patients at base-line and follow-up visit after 6 months.
Analyses of the microbiome composition will be performed and difference in data between study visits will be calculated.

Vastra Gotaland Region

Group A. Pharmacological treatment with TNF-α inhibitor or JAK inhibitor Group B. Physical hand training 10 min twice daily while on stable treatment with TNF-α inhibitor or JAK inhibitor

A patient who has a diagnosis of GCA or PMR

Serum, plasma, cellular and subcellular fractions of blood, urine or arterial tissue, DNA, RNA, proteins and metabolites

Giant Cell Arteritis

Polymyalgia Rheumatica

Stoke Mandeville Hospital - Buckinghamshire Healthcare NHS Trust

Barnsley NHS Foundation Trust

Basildon & Thurrock University Hospital NHS Foundation Trust

Royal National Hospital for Rheumatic Diseases

Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust

Queen Elizabeth Hospital, University Hospitals Birmingham

Queens Hospital, University Hospitals of Derby and Burton NHS Foundation Trust

West Suffolk NHS Foundation Trust

Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

Chelsea and Westminster Hospital NHS Foundation Trust

West Middlesex University Hospital, Chelsea and West Minster NHS Foundation Trust

Ashford & St Peters Hospitals NHS Foundation Trust

Croydon University Hospital

Doncaster Royal Infirmary

Ninewells Hospital and Medical School, NHS Tayside

NHS Lothian, Edinburgh

Royal Devon and Exeter NHS Foundation Trust

Frimley Park Hospital NHS Foundation Trust

Queen Elizabeth Hospital, Gateshead

Inverclyde Royal Hospital, NHS Greater Glasgow and Clyde

Royal Alexandra Hospital, NHS Greater Glasgow and Clyde

Vale of Leven Hospital, NHS Greater Glasgow and Clyde

James Paget University Hospitals NHS Foundation Trust

Royal Surrey County Hospital

Harrogate and District NHS Foundation Trust

Hull Royal Infirmary, Hull and East Yorkshire Hospitals

The Ipswich Hospital, Colchester Hospital University NHS Trust

Airedale General Hospital, Airedale NHS Foundation Trust

Westmorland General Hospital, University Hospitals of Morecambe Bay NHS Foundation Trust

The Queen Elizabeth Hospital, Kings Lynn Foundation Trust

Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust

Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust

Royal Glamorgan Hospital, Cwm Taf University Health Board

Kings College Hospital NHS Foundation Trust, London

Royal Free Hospital, Royal Free London NHS Foundation Trust

University College London NHS Foundation Trust

Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust

The Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust

Northampton General Hospital

Norfolk and Norwich University Hospital Foundation Trust

Queens Medical Centre, Nottingham University Hospitals NHS Trust

Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Trust

Peterborough and Stamford Hospitals NHS Foundation Trust

Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust

Scarborough General Hospital, York Teaching Hospital HS Foundation Trust

Southend University Hospital NHS Foundation Trust

Lister Hospital, East and North Hertfordshire NHS Trust

Haywood Hospital, Staffordshire and Stoke on Trent Partnership NHS Trust

Great Western Hospitals NHS Foundation Trust

St George's University Hospitals NHS Foundation Trust, London

Torbay and South Devon NHS Foundation Trust

Royal Cornwall Hospital NHS Trust

Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust

Warrington and Halton Hospital NHS Foundation Trust

South Warwickshire NHS Foundation Trust

Arrowe Park Hospital, Wirral University Hospital NHS Foundation Trust

York Teaching Hospital NHS Foundation Trust

Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)

UK GCA Consortium: Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)

Diagnosis of GCA (or PMR), confirmed by a specialist (e.g. rheumatologist, ophthalmologist) with relevant expertise.

Clinical phenotype or subtype of GCA/PMR based on disease features and imaging undertaken as part of routine clinical practice, and on research tests, such as imaging performed for research purposes, cells, subcellular fractions and molecules in the circulation and/or arterial tissue and genetic/ epigenetic/ transcriptomic/ proteomic or metabolomic factors, including next generation sequencing (whole exome sequencing) of selected cases.

Assessment of the impact the disease and treatment has on the patients' lives as reported by the patient

Longitudinal follow-up of patients (as far as is possible from medical and electronic records and without requiring additional study visits) to define prognosis/disease outcomes, such as ischaemic manifestations, aneurysm formation, duration of steroid therapy, disease flares, complications related to steroid therapy.

Diagnosis in patients presenting with suspected GCA/PMR (prospective study).

To investigate role of genetics, environmental factors (e.g. diet and sunlight) and co-morbidities (e.g. periodontal disease) on disease phenotype and outcome as assessed by the patient-administered questionnaires.

Participants commencing a synthetic or biological disease modifying anti-rheumatic drug with or without additional steroid therapy will have their disease activity assessed.

A variety of 'omic technologies will be applied to cell populations isolated from the blood and/or routine diagnostic arterial biopsies, including, but not limited to, RNASeq and a variety of proteomic approaches.

Ann Morgan

Professor of Molecular Rheumatology and Honorary Consultant Rheumatologist

University of Leeds

University of Oxford

Newly diagnosed RA patients started on subcutaneous MTX - open randomisation vs. sulfasalazine. In this group, use of NSAIDs, steroids, and/or other DMARDs, is allowed, if indicated, for symptom control. The overall management, tests and outpatient rheumatology visits schedule will be similar to other patients with RA, in accordance to standard practice .

Newly diagnosed RA patients started on sulfasalazine - open randomisation vs. subcutaneous MTX. In this group, use of NSAIDs, steroids, and/or other DMARDs (except MTX), is allowed, if indicated, for symptom control. The overall management, tests and outpatient rheumatology visits schedule will be similar to other patients with RA, in accordance to standard practice.

RA patients on long-term treatment (> 1 year) with oral MTX, with or without other DMARDs, NSAIDs and/or steroids, switched to subcutaneous MTX (same dose). In these patients, treatment with other DMARDs, NSAIDs and/or steroids will continue. The overall management, tests and outpatient rheumatology visits schedule will be similar to other patients with RA, in accordance to standard practice.

RA patients on stable treatment (> 1 year) with other (non-MTX) DMARDs, with or without NSAIDs and/or steroids, and continued on the same treatment. The overall management, tests and outpatient rheumatology visits schedule will be similar to other patients with RA, in accordance to standard practice.

Stiffness, Aortic

Endothelial Dysfunction

Cardiovascular Risk Factor

Methotrexate

Sulfasalazine

Other DMARDs

Southern Adelaide Local Health Network

Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

Change in peripheral systolic blood pressure

Change in peripheral and central blood pressure

Arduino Mangoni

Professor of Clinical Pharmacology

Flinders University

University of South Australia

medac GmbH

Disease activity score(DAS28) matrix metalloproteinase-3(MMP-3) and matrix metalloproteinase-9(MMP-9), Erythrocyte sedimentation rate C- reactive protein Complete blood count Urine analysis Renal and liver function tests Lipid profile, blood glucose level Serum uric acid Rheumatoid factor (RF IgM, U/L) Anti- cyclic citrullinated peptide . Radiological assessment :Plain radiographs of both hands and feet in the postero-anterior views .
Cardiac assessment :By electrocardiogram ( ECG ) and echocardiography , Carotid artery intima-medial thickness (IMT) will be done by colored doppler ultrasound.

Disease activity score(DAS28) Matrix Metalloproteinase-3 (MMP-3) and Matrix Metalloproteinase-9 (MMP-9) Erythrocyte sedimentation rate C- reactive protein Complete blood count Urine analysis Renal and liver function tests Lipid profile, blood glucose level Serum uric acid , Rheumatoid factor (RF IgM(immunoglobulin M), U/L) Anti- cyclic citrullinated peptide. Radiological assessment :Plain radiographs of both hands and feet in the postero-anterior views.
Cardiac assessment :
By electrocardiogram ( ECG ) and echocardiography Carotid artery intima-medial thickness (IMT) will be done by colored doppler ultrasound.

blood and serum samples separated br centrifugation

MMP-3 and MMP-9 will be done with blood samples using ELISA technique CIMT will be done using colored doppler ultrasound

Doxycycline Tablets

Assiut University

Re-evaluation of Some Old Rheumatoid Arthritis Therapy: A Randomized Controlled Trial

Efficacy of Doxycycline as a Combination Therapy in the Treatment of Rheumatoid Arthritis

percentage of patients achieving remission or low disease activity as assessed by DAS28

Eman Mohammed Ibrahem Kamel

principal investigator

A group of patients will receive methotrexate only, another group will receive methotrexate plus doxycycline

antirheumatics/mŕtvica

Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients

Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)

Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

Re-evaluation of Some Old Rheumatoid Arthritis Therapy: A Randomized Controlled Trial

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