Group 1 (n=12): ustekinumab 45 mg (or 90 mg for patients > 100 kg) subcutaneously at baseline (W0), 4 weeks later (W4), and every 12 weeks until week 24 (i.e. W0, W4, and W16).

Group 2 (n=12): guselkumab 100 mg subcutaneously (regardless of the weight of the patient) at weeks 0 and 4, followed by a maintenance dose every 8 weeks through week 24 (i.e. W0, W4, W12 and W20).

Group 3 (n=12): adalimumab 40 mg (regardless of the weight of the patient), subcutaneously every other week, starting from the baseline until week 24 (i.e.W0, W2, W4, W6, W8, W10, W12, W14, W16, W18, W20 and W22).

Psoriatic Arthritis

Global/single cell gene expression profiles obtained from synovial biopsies before and after 24 weeks of treatment with the drug.

Global/single cell gene expression profiles obtained from Synovial biopsies

Dirk ELEWAUT

Adrien NZEUSSEU TOUKAP

TNF and IL23 Blocking Agents Gene Expression Ratios in the Psoriatic Arthritis Synovium_(TIGERS) Study

TNF and IL23 Blocking Agents Gene Expression Ratios in the Psoriatic Arthritis Synovium

The primary endpoint of the study is not the comparative efficacy of the 3 drugs, but the comparative molecular changes they induce in the synovium.
In a first set of analyses, the magnitude of fold-changes in (global and single cell) gene expression profiles between baseline and W24 will be analysed in each group. The higher values correspond to the high intensity in the up-regulation or down-regulation of the gene expression.

The swollen joints count (0 to 66) will be assessed. Lowered scores correspond to an improvement (remission or low disease activity), and increased value to a worsening of the clinical conditions (high disease activity). The value of the joints count will be compared to the magnitude of the up-regulation or down-regulation in the gene expression profiles.

Synovitis (inflammation in the synovium) is scored by US in Grey-Scale (GS) (0 to 3) and Power Doppler (PD) (0 to 3). 0 correspond to lack of inflammation, and 3 to high amount of inflammation. The US changes in GS and PD will be compared to the magnitude of up-regulation or down-regulation in the gene expression profiles.

MRI assessments for synovitis or bone marrow edema (water in the bone's head related to inflammation) will be binary (0 for absence of inflammation, and 1 for presence). MRI changes will be compared to the magnitude of up-regulation or down-regulation in the gene expression profiles.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Janssen-Cilag International NV

University Hospital, Ghent

Patients randomized to continue medical treatment with biologics

Patients randomized to stop medical treatment with biologics

Ulcerative Colitis in Remission

Ultrasound

Relapse/Recurrence

Transabdominal ultrasound of the bowel for categorisation of disease activity

Withdrawal of full blood at each study visit, Storage in biobank. Analysis of prouroguanyline and proguanyline.

Analysis of prouroguanyline and uroguanyline in full blood

Department of Medicine, Haukeland University Hospital

Ålesund Hospital

Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound

Endscopic relapse defined as a MAYO endoscopic subscore ≥2

The clinical outcome for relapse is defined as a 6 point MAYO score ≥2.

Kappa statistics for inter-observer variation of patient classification into the relapse/no relapse categories and for categorical ultrasound parameters such as the ultrasound score (0-3), vascularity with colour Doppler (0-3), stratification of wall layers (0-3), presence of haustrations (0-1), presence of submucosal thickening (0-1), lymph nodes (0-2) and free fluid.

Bland Altman statistics of the continuous ultrasound parameter wall thickness (in mm).

Endscopic relapse defined as a MAYO endoscopic subscore ≥1

Relapse defined as presence of inflammation evaluated by pathologist in mucosal biopsies

spotted/ödəm

TNF and IL23 Blocking Agents Gene Expression Ratios in the Psoriatic Arthritis Synovium_(TIGERS) Study

Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound

Elm tərəfindən dəstəklənən ən tam dərman bitkiləri bazası