Trial · NCT06768294
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The evaluation the effect of baricitinib on inflammation of the synovial membrane in CPPD | The outcome for the primary objective is the changes in the synovial tissue CD68 scoring at 12 weeks, an objective outcome measure. | CD68 score will be used as outcome measure for the primary objective. CD68 score will be calculated from an analysis of 6 images from each biopsy section and expressed as the mean area of tissue occupied by positively stained cells. |
| Secondary | To assess the changes in Krenn synovitis score at the synovial level | 12 weeks | Krenn score will be used to determine the degree of synovitis according to the three synovial membrane features: synovial lining cell layer, stroma cell density, and inflammatory infiltrate. All parameters will be graded with a semiquantitative score (from 0 to 3) as follows: 0 (absent), 1 (slight), 2 (moderate) and 3 (strongly positive). All parameters will be summarized with a final total score by adding the score of the single features (will range from 0 to 9) and interpreted as follows: 0-1: no synovitis; 2-4: low-grade synovitis; 5-9: high- grade synovitis. |
| Secondary | To assess the changes in cytochin levels at the synovial membrane | 12 weeks | The biopsy samples will be immediately placed in 10% neutral buffered formalin fixed for 48 h and embedded in paraffin for histologic and immunohistochemical analyses. Overall staining intensity will be evaluated. The overall score of the staining intensity will be graded in a four degree scale: negative (0), weak (1), moderate (2), and strong (3). |
| Secondary | To determine changes at ultrasound examination in terms of calcium crystal deposition | 4, 12 and 24 weeks | The ultrasound assessment will include the wrists and hands, knees and the affected joints if different than hands/wrists/knees. For CPP deposition, the CPP deposits of knees, wrists and any involved site will be scored with a semi-quantitive score (0-3). |
| Secondary | To determine changes at ultrasound examination in terms of synovitis | 4, 12 and 24 weeks | The ultrasound assessment will include the wrists, hands, knees and the affected joints if different than hands/wrists/knees. Synovitis will be scored according to the semiquantitative Global OMERACT EULAR Scoring System (GLOESS), a semiquantitative score (0-3) that can be interpreted as: no inflammation (0), slight inflammation (1), moderate inflammation (2) and severe inflammation (3) |
| Secondary | To determine changes at ultrasound examination in terms of bone changes | 4, 12 and 24 weeks | The ultrasound assessment will include the wrists and hands, knees and the affected joints if different than hands/wrists/knees. Bone profile irregularities intended as erosions and/or osteo-proliferative changes (osteophytes) will be scored with a dichotomic score (0: absence, 1:presence). |
| Secondary | To evaluate the effect of baricitinib on serum cytokine levels at a plasmatic level. | 12 and 24 weeks | Blood exams will include circulating cytokines dosage will include IL-1, IL-6, IL-8, anti-TNFα, Interferonα and γ, and TGFβ. For cytokine analysis, blood will be immediately centrifuged at 1300g (10 min, 15°C) and serum will be aliquoted and stored at -80°C until assayed. Cytokine concentrations will be assayed in serum by means of customized high-sensitive magnetic beads-based immunoassays, following manufacturer's protocol. Assays will be performed using a Luminex® MagPix instrument. The sensitivities of the assays are: 0.29 pg/ml for interferon α, 1.37 pg/ml for interferon γ, 0.25 pg/ml for IL-1β, 0.38 pg/ml for IL-6, 0.37 pg/ml for IL-8, 0.62 pg/ml for TNFα, and 11.1 pg/ml for TGFβ. |
| Secondary | Change from baseline in joint pain | 4, 12 and 24 weeks | A Visual Analogic Scale (VAS) for pain at the involved joints will be used for this purpose. Each patient will be invited to indicate the severity of pain by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". Measurement from the starting point (left end) of the scale to the patients' mark will be recorded in centimeters and will be interpreted as the pain severity. |
| Secondary | Change from baseline in DAS score | 4, 12 and 24 weeks | The DAS (Disease Activity Score) provides a score between 0 and 10, a larger number indicating more active disease. The disease activity is considered ''high"' if DAS is \> 5,1, which would mean a worse outcome for the patient's global health; ''moderate" if DAS is \> 3,2; ''low'' if DAS is \< 3,2; ''on remission'' if DAS is \< 2,6, which means a better outcome overall. |
| Secondary | Change from baseline in HAQ score | 4, 12 and 24 weeks | HAQ (Health Assessment Questionnaire) is a quantitative tool used to assess health related quality of life assessments related to many types of injuries or illnesses. Each item or question is rated on a scale of 0 to 3, with 0 (normal/no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The categories scores are averaged, which represent an overall score from 0 (no disability) to 3 (completely disabled). |
| Secondary | Change from baseline in WOMAC index | 4, 12 and 24 weeks | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). |
| Secondary | Change from baseline in CD3, CD8, CD20 at synovial level | 12 weeks | Similarly for the primary outcome, the analysis of 6 images from each biopsy section will be analysed and the score will be expressed as the mean area of tissue occupied by positively stained cells for each surface protein. |
| Secondary | To identify subsets of the disease that could have a better response to the treatment | baseline - 24 weeks | Two subsets of CPPD have been considered for this study: acute arthritis and chronic CPP crystal inflammatory arthritis. For each subset the changes of clinical, ultrasonographic and patient repoerted outcomes scores will be monitored and compared in order to identify any differences between the the groups. Details on the assessment of such outcomes have been provided above. |
| Secondary | To determine changes at ultrasound examination in terms of inflammation and degenerative changes | 4, 12 and 24 weeks | The ultrasound assessment will include the wrists and hands, knees and the affected joints if different than hands/wrists/knees. Inflammatory changes (synovitis) will be scored according to the semiquantitative Global OMERACT EULAR Scoring System (GLOESS) a semiquantitative score (0-3) that can be interpreted as: no inflammation (0), slight inflammation (1), moderate inflammation (2) and severe inflammation (3) while bone profile irregularities intended as erosions and/or /osteo-proliferative changes (osteophytes) will be scored with a dichotomic score (0: absence, 1:presence). Each site will be scored separately for both inflammatory and bony changes. |
| Other | To explore the possible baricitinib-induced impact on whole-body metabolism | 24 weeks | Untargeted metabolomics analysis on the same samples will be performed using standardized bioinformatics tools to discover the most relevant metabolic pathways involved in the pathogenesis of CPPD and/or valuable to monitor the therapeutic path of the CPPD patient. Targeted metabolomics will be done to quantify key small molecules involved in the energy cycles and oxidative stress. In this analysis, the metabolites will be extracted from the serum and then their concentrations will be compared to the analytical standards. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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