Trial · NCT01552681
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Screening in Stimulated Whole Salivary Flow at Week 24 | Screening to Week 24 | The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo with screening and post-screening stimulated salivary flow results. Participants missing Week 24 assessment were imputed from last post-screening assessment. Salivary flow results unavailable for one subject. | mL/min | MEAN |
| SECONDARY | Change From Screening in Stimulated Whole Salivary Flow at Week 48 | Screening to Week 48 | The Modified Intent-to-Treat with available data population included all randomized subjects who received \>=1 dose of either baminercept or placebo and who had stimulated salivary flow results at screening and Week 48. Wk 48 stimulated salivary flow results were not available for N=7 subjects (e.g., N=6 in baminercept and N=1 in placebo group). | mL/min | MEAN |
| SECONDARY | Change From Screening in Unstimulated Whole Salivary Flow at Week 24 | Screening to Week 24 | The Modified Intent-to-Treat with available data population included all randomized subjects who received \>=1 dose of either baminercept or placebo and who had an unstimulated salivary flow assessment at screening and week 24. Data were not available for N=7 subjects (e.g., N=5 in baminercept and N=2 in placebo group). | mL/min | MEAN |
| SECONDARY | Change From Screening in Unstimulated Whole Salivary Flow at Week 48 | Screening to Week 48 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had unstimulated salivary flow results at Screening and Week 48. Data were not available for six participants who received baminercept and one participant who received placebo. | mL/min | MEAN |
| 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 Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had an ESSDAI score at Baseline and Week 24. Data were not available for five participants who received baminercept and two participants who received placebo. | units on a scale | MEAN |
| 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 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and one participant who received placebo. | Percent of participants | NUMBER |
| 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 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo. | Percent of participants | NUMBER |
| SECONDARY | Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 | Week 24 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo. | mm | MEAN |
| SECONDARY | Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 | Week 48 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo. | mm | MEAN |
| SECONDARY | Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24 | Week 24 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo. | mm | MEAN |
| SECONDARY | Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48 | Week 48 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo. | mm | MEAN |
| SECONDARY | Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24 | Week 24 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 24. Data were not available for six participants | mm | MEAN |
| SECONDARY | Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48 | Week 48 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 48. Data were not available for six participants | mm | MEAN |
| SECONDARY | Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24 | Week 24 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo. | mm/5 min | MEAN |
| SECONDARY | Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48 | Week 48 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo. | mm/5 min | MEAN |
| SECONDARY | Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24 | Week 24 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48 | Week 48 | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo. | units on a scale | MEAN |
| 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 Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo. | units on a scale | MEAN |
| 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 Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo. | units on a scale | MEAN |
| 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. | The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo. | Percent of participants | NUMBER |
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/NCT01552681/outcomes