Trial · NCT05879458
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Modified Severity Weighted Assessment Tool (mSWAT) | Baseline and Week 24 | Change in Modified Severity Weighted Assessment Tool (mSWAT) at Week 24 from baseline. Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL. Responses in the skin based on SWAT are defined as: Complete Response (CR): no evidence of skin disease Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline. |
| Secondary | Change in Modified Severity Weighted Assessment Tool (mSWAT) | Baseline and at each visit from week 2 to week 48 / EOS except for week 24 | Change in Modified Severity Weighted Assessment Tool (mSWAT) at each visit from baseline. Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL. Responses in the skin based on SWAT are defined as: Complete Response (CR): no evidence of skin disease Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline. |
| Secondary | Treatment Emergent Adverse Events | up to Week 48/EOS | Incidence and severity of treatment-emergent adverse events |
| Secondary | Number of Serious Adverse Events | up to Week 48/EOS | Number of serious adverse events (SAE) leading to discontinuation |
| Secondary | Number of Adverse Events | up to Week 48/EOS | Number of Adverse events (AE) leading to discontinuation |
| Secondary | Number of clinically significant abnormalities in vital signs | up to Week 48/EOS | Number of clinically significant abnormalities in any vital signs |
| Secondary | Number of clinically significant abnormalities in clinical laboratory values | up to Week 48/EOS | Number of clinically significant abnormalities in any clinical laboratory values |
| Secondary | Change in Percentage of patients achieving 50% or greater improvement in mSWAT score | Baseline and at each visit from week 2 to week 48 / EOS | Change in Percentage of patients achieving 50% or greater improvement in mSWAT score (mSWAT50) at every visit as compared to baseline. Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL. Responses in the skin based on SWAT are defined as: Complete Response (CR): no evidence of skin disease Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline. |
| Secondary | Change in Global Response Score | Baseline and at each visit from week 2 to week 48 / EOS | Change in Global Response Score at each vist as compared to baseline. Percentage of patients achieving complete response (CR: 100% improvement), partial response (PR: 50% to 99% reduction from the baseline score), stable disease (SD: \<25% increase to \<50% clearance from baseline), and progressive disease (\>25% worsening above the baseline score) in skin |
| Secondary | Absolute change of health-related quality of life (Skindex-29) | Baseline and at each visit from week 2 to week 48 / EOS | Absolute change of health-related quality of life (Skindex-29 - questionnaire regarding skin conditions) from Baseline up to Week 48. Skindex29 is a 30 question survey that measures quality of life. It is scored from 1-Never to 5-All the time. Full scale from 30-150. The lower the score, the better the quality of life. |
| Secondary | Absolute change of health-related quality of life (FACT-G) | Baseline and at each visit from week 2 to week 48 / EOS | Absolute change of health-related quality of life (FACT-G - questionnaire regarding Physical/Social/Family well being) from Baseline up to Week 48. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). Full scale scored from 0-108. The higher the score, the better the quality of life. |
| Secondary | Absolute change of IPQ-R (Illness perception questionnaire) | Baseline and at each visit from week 2 to week 48 / EOS | Absolute change of IPQ-R (Illness perception questionnaire) from Baseline up to Week 48. The IPQ-R an 70-item instrument developed to provide a quantitative measurement of the components of illness representations. It is divided into three sections: identity subscale (14 symptoms scored as 1-yes or 0-no, subscale from 0-14), views about illness (38 questions scored between 5-strongly agree to 1-strongly disagree, subscale from 38-190) and a third section regarding views on possible causes (18 causes scored between 5-strongly agree to 1-strongly disagree, subscale from 18-90). Full scale from 56-294. High scores on the identity and views of illness sections represent strongly held beliefs about the number of symptoms attributed, the negative consequences, and the chronicity and cyclical nature of the illness. High scores in the section regarding causes represent positive beliefs about controllability and a personal understanding of the illness. |
| Secondary | Percentage change of pruritus according to visual analogue scale (VAS) | Baseline and at each visit from week 2 to week 48 / EOS | Percentage change of pruritus according to visual analogue scale (VAS). Line graph to collect information about general itch level as well as worst itch level in the past 24 hours on a scale of 0 to 10, with higher score indicating more itch from baseline up to week 48. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05879458/registered