Reported trial results for Sjogren's Syndrome

11 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT02962895 · results posted 29 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02962895) tested a medicine called VAY736 in people with Sjögren's syndrome, an autoimmune condition that causes dryness and fatigue, among other symptoms. In the first part of the trial (up to 24 weeks), 190 participants were randomly assigned to receive either a placebo (a dummy treatment) or one of three doses of VAY736 — 5 mg, 50 mg, or 300 mg. The trial used two main scoring tools to track participants over time: the ESSDAI, which is a doctor-assessed measure of disease activity scored from 0 to 123 (where lower is better), and the ESSPRI, which is a patient-reported measure of symptoms such as pain, dryness and fatigue scored from 0 to 10 (where lower is better). The reported data shows that at 24 weeks, scores on the ESSDAI went down (improved) across all groups. The placebo group's score fell by an average of 6.39 points, the 5 mg group by 5.64 points, the 50 mg group by 6.93 points, and the 300 mg group by 8.30 points. For the patient-reported ESSPRI score at 24 weeks, the reported reductions were similar across groups: 1.71 points for placebo, 1.39 points for 5 mg, 1.70 points for 50 mg, and 1.77 points for 300 mg. A fatigue questionnaire called the FACIT-F (scored 0–52, where higher scores mean less fatigue) also showed changes across all groups over 24 weeks — scores rose by 9.05 points in the placebo group, 7.12 points in the 5 mg group, 6.48 points in the 50 mg group, and 9.36 points in the 300 mg group. The reported data shows that changes in scores were observed in all groups — including those receiving the placebo — across all three measures and at all time points recorded. The trial also included a second phase running from weeks 24 to 52, in which 90 participants continued; however, separate outcome numbers for that phase were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04988087 · results posted 8 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04988087) enrolled 30 people across four groups. Twelve people received the study drug MHV370 (200mg) and 14 received a placebo (dummy treatment) for a condition called Sjögren's syndrome (SjS) — a disease that affects moisture-producing glands. A further 2 people received MHV370 and 2 received placebo for a condition called Mixed Connective Tissue Disease (MCTD). The trial ran for 24 weeks and was measuring changes in disease activity scores, fatigue, and how the drug moved through the body. Notably, a large number of participants did not complete the study — none of the 12 people in the MHV370/SjS group finished, and only 4 of the 14 in the placebo/SjS group completed it. The reported data shows that for the Sjögren's syndrome participants, the primary measure was a disease activity score called ESSDAI (scored 0–123, where higher means more severe). A result was only reported for the placebo group, showing a change of −4.39 points from the start (a negative number indicating a reduction in score). A corresponding figure for the MHV370 group was not reported in the data. For the MCTD group, the primary measure was a doctor's rating of disease activity on a 0–100 scale; a change of −62.00 points was reported for the MHV370 group only, with no figure reported for the MCTD placebo group. The reported data also shows how MHV370 was absorbed into the bloodstream: peak drug levels were 278 ng/mL in SjS participants and 194 ng/mL in MCTD participants, reached within 1.5 to 2 hours of dosing. Fatigue scores (measured on a 0–52 scale, higher meaning worse) showed varying changes across groups and time points, with some groups showing small increases and others showing decreases in their scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04093531 · results posted 25 June 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04093531) enrolled 12 people, all of whom received the drug ustekinumab. The trial was looking at Sjögren's syndrome — a condition that causes dryness, fatigue and pain — and ran for 24 weeks. Of the 12 people who started, 8 completed the trial and 4 did not. The main thing the trial was measuring was whether participants' self-reported symptoms — specifically dryness, fatigue and pain — changed over those 24 weeks, using a questionnaire called the ESSPRI (where 0 means no symptoms and 10 means the worst imaginable symptoms). The reported data shows that the average ESSPRI score across the group changed by minus 0.125 points from the start to week 24 — meaning the average score was very slightly lower at the end. For a separate quality-of-life questionnaire (the SF-36, where higher scores reflect a more favourable state), the reported data shows average score changes of +11.1 for physical function, +7.5 for energy/fatigue, +5.25 for pain, and +0.6 for general health. The trial also measured disease activity using a clinician-assessed tool called the ESSDAI — the reported average score was 2.86 at the start and 1.75 at week 24. Finally, the reported data includes changes in various inflammation-related markers measured in the blood; these figures ranged widely across the different markers measured, but the trial results as submitted did not include the individual marker labels matched to each number, so a full breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT03445650 · results posted 9 February 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03445650) enrolled 11 people in total — 7 in the group using ADX-102 1% Topical Dermal Cream and 4 in the group using a vehicle cream (a cream without the active ingredient, used for comparison). Of those, 6 people in the ADX-102 group and 3 in the vehicle group completed the trial. The trial was measuring changes in skin scaling in people with ichthyosis (a condition that causes very dry, scaly skin) using a scoring tool called the Visual Index Ichthyosis Severity (VIIS) Scaling Score, which runs from 0 (least severe) to 4 (most severe). The reported data shows that the primary outcome measured was the change in the VIIS scaling score from the start of the trial to the end, but only for the ADX-102 group. The average score in that group changed by −0.7 units on the scale, meaning the score was slightly lower (less severe) at the end compared to the beginning. No corresponding change figure was reported for the vehicle cream group in the data submitted to ClinicalTrials.gov, so a direct comparison between the two groups cannot be drawn from the available figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT04035668 · results posted 20 December 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04035668) enrolled 73 people with Sjögren's Syndrome — a condition that affects the immune system and causes dryness, pain, and fatigue. Participants were randomly assigned to one of three groups: remibrutinib taken twice daily (24 people), remibrutinib taken once daily (25 people), or a placebo (an inactive treatment, 24 people). The trial ran for 24 weeks and was primarily measuring changes in a standardised disease activity score called the ESSDAI, which rates how active Sjögren's Syndrome is across 12 body systems on a scale of 0 to 123 (higher scores mean more active disease). A number of other scores — covering patient-reported symptoms, fatigue, quality of life, and the treating doctor's overall assessment — were also tracked as secondary measures. The reported data shows that on the primary measure (the ESSDAI score at 24 weeks), all groups showed a reduction from their starting scores, meaning scores moved in a lower — or less active — direction. The once-daily remibrutinib group showed a reported change of −4.70 points, the twice-daily group −3.70 points, and when both remibrutinib groups were combined the figure was −4.20 points. The placebo group showed a reported change of −1.34 points. On the secondary measures, the reported data shows that scores for patient-reported symptoms (ESSPRI), fatigue (FACIT-F), general health (EQ-5D), and doctor-rated disease activity (PhGA) also changed across all groups over the course of the trial, with the numbers varying between groups and across different time points. Some of these changes were small and the direction of change was not always consistent across groups at every time point. It is worth noting that this was a relatively small study — roughly 24–25 people per group — and a number of participants did not complete the trial (7 in the twice-daily group, 8 in the once-daily group, and 3 in the placebo group). The reported data does not include information about why participants left the trial early. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02402309 · results posted 13 December 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02402309) involved 12 people in total — 6 who used a cream called NS2 1% Dermatologic Cream applied to the skin, and 6 who used a vehicle cream (a comparison cream containing no active ingredient, sometimes called a placebo). All 12 participants completed the study with no one dropping out. The trial was primarily measuring whether participants experienced certain negative health events while using these creams. The reported data shows that the two main things being tracked were: (1) whether any participant experienced a "serious adverse event" — meaning a significant or severe unwanted health problem — and (2) whether any participant had an unwanted health problem serious enough to cause them to stop using the cream. According to the results reported on ClinicalTrials.gov, the number of participants who experienced either of these events was zero in both groups — that is, no participants in either the NS2 cream group or the comparison cream group had a serious adverse event or stopped the study due to an adverse event. No other outcome measures were included in the submitted results data. It is worth noting that this was a very small trial with only 6 people in each group, and only these two specific safety-related outcomes were reported — no other measures of how the cream performed were included in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT02257957 · results posted 24 August 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02257957) involved 30 people in total — 15 who received Platelet-Rich Plasma (PRP) eye drops and 15 who received standard care for dry eye. All 30 participants completed the study, with no drop-outs in either group. The trial was measuring changes in three things: the degree of surface damage to the eye (using a grading system called the Oxford Scale, scored from 0 to 5), the amount of moisture the eye produces (using a test called the Schirmer test, measured in millimetres), and how much dry eye symptoms affected daily life (using a questionnaire called the OSDI, scored from 0 to 100 where higher scores mean more severe symptoms). The reported data shows the following results at the end of the study. For eye surface damage (Oxford Scale), the PRP group recorded an average score of 1.2, compared with 2.4 in the standard care group — noting that lower scores on this scale indicate less surface damage. For the moisture test (Schirmer test), the PRP group recorded an average of 9.2 mm of moisture, compared with 5.3 mm in the standard care group. For the symptom questionnaire (OSDI), the PRP group recorded an average score of 34, compared with 55 in the standard care group — where lower scores indicate fewer or less severe symptoms. It is important to note that these figures represent the change from the participants' starting point, but the exact baseline (starting) values were not included in the data reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02193490 · results posted 5 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people in total — 25 in the DNase group and 22 in the vehicle (comparison/control) group. Of those, 21 and 20 respectively completed the study. The trial was measuring changes in two main things over 8 weeks: the appearance of the eye's surface using a special dye called Rose Bengal (which highlights any damage to the cornea, the clear front part of the eye), and how much dry eye symptoms affected participants' daily lives, measured using a 12-question survey called the OSDI. A separate exploratory measure looked at the amount of mucous debris on the eye's surface. The reported data shows that, on average, participants in the DNase group had a change of −1.00 points on the Rose Bengal corneal staining scale (where lower scores indicate less staining, on a scale of 0–15), while the vehicle group showed a change of 0.00 points. For the OSDI symptom questionnaire (scored 0–100, where higher scores indicate more severe symptoms), the DNase group showed an average change of −20.75 points, compared with −8.43 points in the vehicle group. For the mucous debris measure, the DNase group showed a change of −1.00 at one time point and 0.00 at another, while the vehicle group showed 0.00 at both time points. These are the changes from the starting point — negative numbers mean scores went down over the course of the study. It is important to note that these figures simply describe what was recorded and reported. The reported data shows numbers from a relatively small group of participants, and what these results mean more broadly was not elaborated on in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02066896 · results posted 3 August 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people in total — 33 in a group that received active laser therapy and 33 in a group that received a sham (fake) version of the same laser therapy, meaning neither group knew which treatment they were getting. All 66 participants completed the trial with no drop-outs. The trial was measuring dry mouth symptoms, saliva flow, and a protein in saliva linked to a condition called Sjögren's syndrome — an illness where the immune system attacks the glands that make saliva and tears. The reported data shows that dry mouth symptoms were measured using an 11-question survey called the Xerostomia Inventory, where scores range from 5 (least severe) to 55 (most severe), and a difference of 6 or more points is considered meaningful. At the end of the study, the sham group recorded an average score of 40.2 and the active laser therapy group recorded an average score of 39.3 — a difference of less than one point between the two groups. For saliva flow, the reported data shows both groups recorded the same average of 0.100 millilitres per minute. Regarding the saliva protein called beta-2 microglobulin — a marker thought to reflect inflammation in the salivary glands — the sham group averaged 1.10 micrograms per millilitre and the active laser group averaged 0.84 micrograms per millilitre. The reported data does not include any information about statistical analysis or whether the differences between the two groups were considered significant by the researchers, so no further interpretation of these numbers is possible from the submitted results alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00344448 · results posted 21 December 2015

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called Raptiva compared to a placebo (a dummy treatment with no active ingredient) in people with a condition affecting saliva and tear production. The trial had two main phases — a 12-week blinded phase (where neither participants nor doctors knew who was getting which treatment) followed by an open-label phase (where everyone knew). A total of 10 people entered the screening stage, with 6 assigned to Raptiva and 3 to placebo going on to the blinded phase. By the end of the full trial, only a small number of participants had completed all stages. The reported data shows that the main thing being measured was whether participants were "responders" at 12 weeks — meaning they showed meaningful improvement in at least two out of three body measurements (saliva flow, salivary gland tissue examined under a microscope, and tear flow) without getting worse in the third. According to the results reported on ClinicalTrials.gov, at the end of the 12-week blinded phase, 0 out of 6 participants in the Raptiva group met the criteria to be counted as a responder, while 1 out of 3 participants in the placebo group did. No secondary outcome measure results were reported in the submitted data. It is worth noting that this was a very small trial — fewer than 10 people completed the main phase — so the numbers represent a very limited group. The reported data shows only what was measured and counted in this particular study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01647737 · results posted 18 March 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in each group. One group used a green tea lozenge, while the other used a placebo (a dummy lozenge with no active ingredient). The trial was looking at people experiencing xerostomia, which simply means a dry mouth condition, and it measured whether saliva flow changed over the course of the study. Of those who started, 26 people in the green tea lozenge group and 25 in the placebo group completed the trial. The reported data shows that the trial measured saliva flow in millilitres per minute (ml/min), comparing each group's starting level to their level at the end. The green tea lozenge group had a reported change of 0.17 ml/min at one measured time point and 0.66 ml/min at another. The placebo group had a reported change of 0.10 ml/min at the first time point and 0.04 ml/min at the second. It is worth noting that the data as submitted does not include additional details such as the specific timing of these measurements or measures of variability, so those figures were not reported and cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.