Trial · NCT05832034
Add-on Intravenous Immunoglobulins in Early Myositis
NCT05832034, Phase 2, Phase 3, Active not recruiting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Add-on Intravenous Immunoglobulins in Early Myositis. Trials, record NCT05832034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05832034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Add-on Intravenous Immunoglobulins in Early Myositis
- NCT number
- NCT05832034
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Conditions
- Inflammatory Myopathy, Idiopathic, Dermatomyositis, Antisynthetase Syndrome, Immune-Mediated Necrotizing Myopathy, Polymyositis, Myositis
- Interventions
- Immune Globulin Intravenous (Human), Placebo
- First posted
- 2023-04-27
- Last updated
- 2026-02-27
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05832034
GET https://conductscience.org/api/trials/v1/NCT05832034/registered?page=2