Trial · NCT01552681
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 From Screening in Stimulated Whole Salivary Flow at Week 24 | Screening to Week 24 | After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening. |
| Secondary | Change From Screening in Stimulated Whole Salivary Flow at Week 48 | Screening to Week 48 | After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening. |
| Secondary | Change From Screening in Unstimulated Whole Salivary Flow at Week 24 | Screening to Week 24 | The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening. |
| Secondary | Change From Screening in Unstimulated Whole Salivary Flow at Week 48 | Screening to Week 48 | The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening. |
| Secondary | Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24 | Baseline to Week 24 | The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24 | Week 24 | Response is defined by 30% or more improvement (decrease) from baseline to week 24 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain. |
| Secondary | Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48 | Week 48 | Response is defined by 30% or more improvement (decrease) from baseline to week 48 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain. |
| Secondary | Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 | Week 24 | On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 | Week 48 | On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24 | Week 24 | Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48 | Week 48 | Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24 | Week 24 | A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48 | Week 48 | A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24 | Week 24 | A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening. |
| Secondary | Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48 | Week 48 | A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening. |
| Secondary | Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24 | Week 24 | Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48 | Week 48 | Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening. |
| Secondary | Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24 | Week 24 | The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening. |
| Secondary | Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48 | Week 48 | The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening. |
| Secondary | Percent of Participants With Adverse Events of Grade 3 or Higher | From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. | Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug. |
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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