Trial · NCT02753530
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score | Change from Baseline to Month 20 | Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person. |
| Secondary | Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score | Change from Baseline to Month 12 | Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person. |
| Secondary | Grip Strength | Change from Baseline to Month 12 and 20 | Unilateral hand grip strength in both hands measured using the Jamar Dynamometer. Results are for the stronger limb, as identified at baseline. |
| Secondary | Modified Timed up and go (mTUG) | Change from Baseline to Month 12 and Month 20 | The patient's combined ability to rise from a chair and walk 3 meters, turn around and walk back to the chair and sit down. The test was performed twice and the fastest time was used. The results were expressed as velocity in meters/second. |
| Secondary | Manual Muscle Testing (MMT), Total Score | Change from Baseline to Month 12 and Month 20 | The Manual Muscle Testing (MMT) scores the strength of 24 muscles (axial, proximal, and distal muscles, tested bilaterally) on a scale from 0 to 10 points. The total score is calculated as an average across the 24 muscles and ranges from 0 to 10. The total score will increase if a patient is getting stronger and decrease if a patient is getting weaker. |
| Secondary | 6 Minute Walk Test (6MWT); Distance After 6 Minutes (6MWD) | Change from Baseline to Month 12 and Month 20 | The distance patients could walk in 6 minutes. The distance walked in meters was recorded after 6 minutes. |
| Secondary | Short Form-36 (SF-36) Physical Component Score | Change from Baseline to Month 12 and Month 20 | Measured using the Short Form health survey with 36 items (SF-36). The questionnaire measures 8 health concepts which yields 2 summary measures: physical and mental health. The physical component score includes 4 scales of physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), and general health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100, and the summary measure is calculated as the average score. Higher scores indicate better health status. |
| Secondary | Maximum Voluntary Isometric Contraction (MVICT) of Quadriceps | Change from Baseline to Month 12 and Month 20 | Unilateral strength of the knee extensor muscles on both limbs using the MicroFET hand-held dynamometer. Results are for the stronger limb, as identified at baseline. |
| Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) | Change from Baseline to Month 12 and Month 20 | The disability index of the HAQ measures self-reported functional status (disability) including the patient's use of aids or devices and/or help from other persons. The scale is composed of 20 items in 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities). Each domain has at least 2 subcategory items, scored on a scale from 0 to 3, and for each of the 8 domains the domain score was the highest score of the involved subcategory scores. The total score reported is an average over 8 domains and scores from at least 6 domains had to be available for the total score to be calculated. The average total score ranges from 0 to 3, and a higher score corresponds to a worsening in functional status. |
| Secondary | 2 Minute Walk Test (2MWT) | Change from Baseline to Month 12 and Month 20 | The distance patients could walk in 2 minutes (during the 6 Minute Walk Test) recorded in meters. |
| Secondary | Short Form-36 (SF-36) Mental Component Score | Change from Baseline to Month 12 and Month 20 | Measured using the Short Form health survey with 36 items (SF-36). The questionnaire measures 8 health concepts which yields 2 summary measures: physical and mental health. The mental component score is composed of energy/fatigue (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and emotional well-being (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100, and the summary measure is calculated as the average score. Higher scores indicate better health status. |
| Secondary | Patient Global Impression of Severity (PGIS) | Change from Baseline to Month 12 and Month 20 | Patient-reported assessment of the impact of IBM on the ability to complete activities of daily living (e.g. dressing, walking, bathing) at the time of the assessment. The response options for the impact of IBM were "none" (i.e. no impact), "very mild", "mild", "moderate", "severe", and "very severe". |
| Secondary | Patient Global Impression of Change (PGIC) | Change from Baseline to Month 12 and Month 20 | Patient-reported assessment of the change from start of study treatment in the impact of IBM on the ability to complete activities of daily living (e.g. dressing, walking, bathing). The response options for change in impact were "very much worse", "much worse", "a little worse", "no change", "a little improved", "much improved", and "very much improved". |
| Secondary | Clinician Global Impression of Severity (CGIS) | Change from Baseline to Month 12 and Month 20 | Clinician-reported assessment of the severity of the patient's IBM symptoms at the time of the assessment. The response options were "none", "very mild", "mild", "moderate", "severe", and "very severe" |
| Secondary | Clinician Global Impression of Change (CGIC) | Change from Baseline to Month 12 and Month 20 | Clinician-reported assessment of the change from start of study treatment in the patient's IBM symptoms. The response options for change in IBM were "very much worse", "much worse", "a little worse", "no change", "a little improved", "much improved", and "very much improved". |
| Secondary | Falls and Near Falls | Accumulated number from Baseline to Month 20 | Falls and near falls registered by the participants in a diary |
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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