64 active RA patients (DAS28>3,2 AND presence of ≥2 US synovitis with Power-Doppler≥2) with an inadequate response to methotrexate (MTX) starting a treatment with JAKi (tofacitinib ou baricitinib) will be evaluated at baseline, 1, 3 and 6 months in 5 centres.
A clinical joint assessment will be performed and CRP will be tested to calculate DAS28-CRP. Several PROs will be completed: RAPID3, HAQ, pain, and patient global assessment of disease activity on a VAS.
An US exam on 40 joints and 12 tendons will be performed by an independent investigator, looking for synovitis and tenosynovitis with B-Mode and Power Doppler. A Global US score (GLOESS) will be collected at each visit.

Rheumatoid Arthritis

An Ultrasound exam (not performed in routine care) will be performed at Baseline, 1, 3 and 6 months for protocol.
All patients will also have CRP dosage (for DAS28 assessment), RAPID-3 and PROs (performed in routine care but analyzed for the study).

Ultrasound

Rheumatology Department, Lapeyronie Hospital

JAKPOT (JAK Inhibitors and Predictors of Outcome in rheumaToid Arthritis)

Added Value of Early Collected Ultrasound as Compared to Clinical Evaluation to Predict Definite Clinical Outcome and Therapeutic Response in Rheumatoid Arthritis Patients Treated by JAK Inhibitors

DAS28-CRP evaluated by an ultra-sound-blinded investigator (score calculated with number of painful articulations, synovitis, and C-Reactive Protein ; DAS28 result > 3,2 : moderately active rheumatoid arthritis)

DAS28-CRP evaluated by a blinded investigator

GLOESS-US evaluated by a blinded investigator

Health assessment evaluated by RAPID3 questionnaire (Routine Assessment of Patient Index Data 3), a validated questionnaire assessing 3 domains : physical function, pain and disease activity. To calculate RAPID-3 scores, each of the 3 individual measures (Patient Global Activity on a visual analogic scale [VAS], pain [VAS] and function were scored from 0-10 for a total of 30. High scores represent the most altered health state. Cut-off value of disease activity were defined and validated: RAPID3 ≤3: Remission; RAPID3 between 3.1 and 6.0: Low disease activity; RAPID3 between 6,1 and 12: moderate disease activity; RAPID3 >12: high disease activity.

Health assessment evaluated by HAQ, a validated Health Assessment Questionnaire disability index for rhumatoid arthritis (score range from 0: no difficulties, to 3: patient disability)

Pain evaluated by patient with VAS (visual analog scale) from 0 to 100

Disease activity evaluated by patient with VAS (visual analog scale) from 0 to 100

University Hospital, Montpellier

Centre Hospitalier Universitaire de Nīmes

University Hospital, Clermont-Ferrand

University Hospital, Bordeaux

University Hospital, Toulouse

Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Progressive aerobic walking exercise will be performed three days in a week. Exercise intensity will be 50- 80% of maximal heart rate and exercises will be performed 45 minutes in per session for 8 weeks.

Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks.

Clinical pilates exercise

Aerobic exercise

Clinical Pilates and Aerobic Exercise

Gazi University

Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis

The 6-minute walk test is a submaximal exercise test used to quantify the functional exercise capacity in clinical populations. It measures the distance walked within a period of 6-minutes.

Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7

The Beck Depression Inventory (BDI) is world-wide among the most used selfrating scales for measuring depression. BDI consists of 21 items related to depressive symptoms such as pessimism, sense of failure, guilt, dissatisfaction, sleep, appetite and fatigue. Each item is scored between 0 and 3. Total score is 63, and an increase of the score means increased severity of depression. According to this scale 1-10 points are defined as normal, scores between 11-16 indicate mild mental distress, 17-20 indicate the patient is at the border points for clinical depression, 21-30 indicate moderate depression, severe depression scores are between 31-40 and 40 points above are interpreted as a very serious depression.

This questionnaire consists of 11 sensory and 4 affective descriptive words. These 15 words are described as 0 = absent, 1 = mild, 2 = moderate, 3 = severe pain. So three type of pain scores (sensory, affective, total = sensory + affective) are obtained. In McGill Pain Questionnaire, the current level of pain is measured by Visual Analog Scale (VAS) and Likert scale consisting of 6 points (0 = no pain, 1 = mild, 2 = irritating, 3 = bothersome, 4 = terrible, 5 = unbearable).

The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.

Disease Activity Score (DAS) is an assessment tool used to measure the level of disease activity in patients with RA. The DAS combines information from swollen joints, tender joints, erythrocyte sedimentation rate (ESR), and patient self-report of general health

The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is a disease-specific quality of life measure that was developed simultaneously in the UK and the Netherlands. The content of the RAQoL was derived from in-depth qualitative interviews with RA patients exploring.
the impact of RA on their QoL.

Songul Baglan Yentur

Research Assistant

In this group subjects will receive 1 vitamin D3 capsule of 50,000 units, each week, for 12 weeks.

In this group the subjects will receive 1 placebo capsule each week for 12 weeks.

Fibromyalgia

D Vitamin Deficiency

Women diagnosed with Fibromyalgia from the outpatient clinic of the "Dr. José Eleuterio González" University Hospital of the Autonomous University of Nuevo Leon.

Subjects will receive a capsule of 50,000 units of vitamin D3 echa week for 12 weeks, basal levels of vitamin D will be taken and again at week 12.

D3 Vitamin

Placebo

Universidad Autónoma de Nuevo León

Valuation of Efficacy and Safety of Vitamin D3 Use in 80 Women Diagnosed With Fibromyalgia. Using FIQ Score and VAS.

Randomized, Double-blind, Placebo-controlled Trial to Measure the Efficacy and Safety of Vitamin D3 in Patients With Fibromyalgia.

Number of items in scale: The version from 19911 consisted of 10 items with 10 sub-items in the physical function scale (total items + sub-items = 19). The modified version from 1997 consists of 20 items with 11 physical function items (total items + sub-items = 30). The 2009 version consists of 21 items across the 3 domains of Function (n = 9), Overall Impact (n = 2), and Symptoms (n = 10).
Subscales: Subscales from the 1991 version1 include physical function (10 sub-items), feel good (1 item), missed work (1 item), do job (1 item), pain (1 item), fatigue (1 item), rested (1 item), stiffness (1 item), anxiety (1 item), and depression (1 item).

Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.

It will be agreed with all participating researchers.

Luis Ivan Lozano Plata

Universidad Autonoma de Nuevo Leon

Longitudinal, prospective, interventional, randomized.

Double blind, the subject of study and researcher.

The patients are given the mushroom extract (Andosan) in doses 30 mlx2 per day for 1 days. The experimental group is selected by randomisation.

The control group is selected by randomisation.

The mushroom extract (Andosan) is given orally in doses 30 m x 2 daily for 21 days

Mushroom extract

Lillehammer Hospital for Rheumatic Diseases

Effect of Andosan in Patients With Rheumatoid Arthritis

Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)

The symptom score will be registered at day 1 prior to the patients are given Andosan for 21 days, and at day 21 after the patients have consumed Andosan daily for 21 days.

Cytokine levels will be measured at day 1 prior to ingestion of Andosan and at day 21 after 21 days of Andosan consumption.

The patients will be registerd for life quality prior to ingestion of Andosan at day 1 and at day 21 after daily ingestion of Andosan for 21 days.

synovitis/únava organizmu

JAKPOT (JAK Inhibitors and Predictors of Outcome in rheumaToid Arthritis)

Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis

Valuation of Efficacy and Safety of Vitamin D3 Use in 80 Women Diagnosed With Fibromyalgia. Using FIQ Score and VAS.

Effect of Andosan in Patients With Rheumatoid Arthritis

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