Trial · NCT05832034
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Improvement Score (TIS) | Week 12 | The primary outcome is the Total Improvement Score (TIS) of the myositis response criteria after 12 weeks, measured as the difference of the mean TIS after 12 weeks between intervention and control groups. Total Improvement Score (TIS) is based on 6 validated core set measures (CSMs), which each determine disease activity as defined by the International Myositis Assessment and Clinical Studies (IMACS) group. TIS ranges between 0 and 100 and corresponds to a degree of improvement; higher scores correspond to a greater degree of improvement. |
| Secondary | Total Improvement Score (IMACS). | TIS will be assessed at t = 0, and after 4, 8, 12, 26 and 52 weeks | Total Improvement Score (TIS) is based on 6 validated core set measures (CSMs), which each determine disease activity as defined by the International Myositis Assessment and Clinical Studies (IMACS) group. TIS ranges between 0 and 100 and corresponds to a degree of improvement; higher scores correspond to a greater degree of improvement. |
| Secondary | Moderate improvement proportion | Examined at week 12 | This is defined as proportion of patients in each treatment group that reaches moderate improvement, i.e. Total Improvement Score of ≥40. Total Improvement Score is based on 6 validated core set measures (CSMs), which each determine disease activity as defined by the International Myositis Assessment and Clinical Studies (IMACS) group. |
| Secondary | Time to response (TIS>40 points) | Will be examined at week 4, 8, 12, 26 and 52 weeks. | This is defined as the time is taken to reach a Total Improvement Score \> 40 points.Total Improvement Score is based on 6 validated core set measures (CSMs), which each determine disease activity as defined by the International Myositis Assessment and Clinical Studies (IMACS) group. |
| Secondary | Core set measures (CSM) - physician global activity (PhGA) | CSMs will be assessed at baseline, week 4, 8, 12, 26 and 52. | 1\. physician global activity (PhGA): assessment of global disease activity on a 10 cm Visual Analogue Scale (VAS) by the treating physician. 0 = no disease activity, 10 most activity On a total of 6 CSM |
| Secondary | Core set measures (CSM) - patient global activity (PGA) | CSMs will be assessed at baseline, week 4, 8, 12, 26 and 52. | 2\. patient global activity (PGA): assessment of global disease activity on a 10 cm VAS by the patient. 0 = no disease activity, 10 most activity On a total of 6 CSM |
| Secondary | Core set measures (CSM) - Manual Muscle Testing (MMT) | CSMs will be assessed at baseline, week 4, 8, 12, 26 and 52. | 3\. Manual Muscle Testing (MMT): sum score of 12 proximal+distal and 2 axial muscle groups. Score 0 - 260 (no muscle weakness). 0 = zero contractions in muscle, 10 = normal On a total of 6 CSM |
| Secondary | Core set measures (CSM) - Health Assessment Questionnaire (HAQ) | CSMs will be assessed at baseline, week 4, 8, 12, 26 and 52. | 4\. Health Assessment Questionnaire (HAQ): average of a survey scoring 8 domains, from 0 (without any difficulty) to 3 (unable to do) On a total of 6 CSM |
| Secondary | Core set measures (CSM) - Serum muscle enzyme activities | CSMs will be assessed at baseline, week 4, 8, 12, 26 and 52. | 5\. Serum muscle enzyme activities expressed as the most abnormal one in the upper limit of normal. On a total of 6 CSM |
| Secondary | Core set measures (CSM) - Extramuscular disease activity | CSMs will be assessed at baseline, week 4, 8, 12, 26 and 52. | 6\. Extramuscular disease activity on a 10 cm VAS based on the Myositis Disease Activity Assessment, measuring the degree of disease activity of extra-muscular organ systems. Score is based on a 0 - 4 scale, related to worsening or improvement. On a total of 6 CSM |
| Secondary | Patient-Reported Outcome Measures (PROMs) questionnaire - Fatigue | At baseline, and after 4, 8, 12, 26 and 52 weeks. | These PROMs relate to different aspects of quality of life, this questionnaire specified on fatigue. The three PROMs are offered as Short Forms: fixed set of 4-10 questions for one of each domain. Each item is scored on a 5-point Likert scale, with higher scores indicating better functioning, and item category responses range from 1 to 5. For example: 1= not at al, 2 = a little, 3 = moderately, 4 = mostly, 5= completely. |
| Secondary | Patient-Reported Outcome Measures (PROMs) questionnaire - Pain interference | At baseline, and after 4, 8, 12, 26 and 52 weeks. | These PROMs relate to different aspects of quality of life, this questionnaire specified on pain interference (in life). The three PROMs are offered as Short Forms: fixed set of 4-10 questions for one of each domain. Each item is scored on a 5-point Likert scale, with higher scores indicating better functioning, and item category responses range from 1 to 5. For example: 1= not at al, 2 = a little, 3 = moderately, 4 = mostly, 5= completely. |
| Secondary | Patient-Reported Outcome Measures (PROMs) questionnaire - Physical function | At baseline, and after 4, 8, 12, 26 and 52 weeks. | These PROMs relate to different aspects of quality of life, this questionnaire specified on physical function. The three PROMs are offered as Short Forms: fixed set of 4-10 questions for one of each domain. Each item is scored on a 5-point Likert scale, with higher scores indicating better functioning, and item category responses range from 1 to 5. For example: 1= not at al, 2 = a little, 3 = moderately, 4 = mostly, 5= completely. |
| Secondary | Fatigue | At baseline, and after 4, 8, 12, 26 and 52 weeks. | The second most important domain according to patients with myositis and health-care providers (OMERACT study group). We will use the Checklist Individual Strength (CIS)-fatigue, a generic fatigue scale, which has been validated in neuromuscular disorders. |
| Secondary | Health related quality of life (HR-QoL) | At baseline, and after 4, 8, 12, 26 and 52 weeks. | HR-QoL will be assessed with EuroQol Group Health Questionnaire (EQ5D). EQ5D is a widely used questionnaire for assessment of general health and has shown responsivity in our previous study on monotherapy IVIg in IIM |
| Secondary | Physical activity | Two consecutive weeks, at baseline, week 4, week 8 and week 26. | Accelerometry will be used to measure physical activity, patients will be offered a wrist-worn wearable (Actigraph GT9X32). For accelerometry we will calculate the mean number of steps and the mean number of flights of stairs per 24 hours, during the 5 most active days per week. |
| Secondary | Mean daily prednisone dosage | Calculated at week 4, 8, 12, 26 and 52. | Start dosage 1 mg/kg (maximum 80 mg). A standard tapering scheme in the first months consists of 10 mg reduction of dosage every 4 weeks. |
| Secondary | MRI abnormalities | At baseline, and after 12 and 26 weeks. | Indicative for edema (T2/STIR) and fatty infiltration (T1) on total body MRI. The MRI results will be used as a marker of inflammation and disease damage, respectively. Sum scores of semi-quantitatively rated muscle, fascial and subcutaneous edema and fatty infiltration will be calculated. |
| Secondary | IgG blood levels. | Obtained immediately before, immediately after and two weeks after the administration of study medication | Immunoglobulin G (IgG) levels in serum samples will be measured by turbidimetry. |
| Secondary | Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI). | At baseline, and after 4, 8, 12, 26 and 52 weeks. | In the subgroup of patients with dermatomyositis, this validated tool will be used to characterize cutaneous dermatomyositis severity and detect improvement in disease activity. |
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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