Trial · NCT01146652
Outcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose (i.e., Day 1 of study LTS11210) up to 60 days after last dose (maximum duration: up to 523 weeks) | Analysis was performed on safety population which included all enrolled participants who had received at least one dose of the study treatment in LTS11210. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Sub-study: Number of Participants Reported Product Technical Complaints (PTC), Product Technical Failures (PTF) and/or Failed Drug Deliveries (FDD) With Pre-filled Syringe With Safety System | From Week 24 to 36 | Analysis was performed on all participants who were enrolled in the sub-study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Sub-study: Number of Product Technical Complaints - Product Technical Failures With Pre-filled Syringe With Safety System | From Week 24 to 36 | Analysis was performed on all participants who were enrolled in the sub-study. | PTF | NUMBER |
| PRIMARY | Sub-study: Number of Failed Drug Deliveries Associated With Pre-filled Syringe With Safety System | From Week 24 to 36 | Analysis was performed on all participants who were enrolled in the sub-study. | FDD | NUMBER |
| PRIMARY | Sub-study: Number of Product Technical Complaints With Pre-filled Syringe With Safety System | From Week 24 to 36 | Analysis was performed on all participants who were enrolled in the sub-study. | PTC | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | Analysis was performed on safety population which included participants who had at least 1 dose of study treatment in LTS11210. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Activity Score for 28 Joints (DAS28) Remission | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field denotes that data were not planned to be collected and analyzed for the specified time-points in the respective groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Good Response, Moderate Response or Non-response Using the European League Against Rheumatism (EULAR) Response Criteria | At Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field denotes that data was not planned to be collected and analyzed for the specified time-points in the respective groups. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in DAS28-CRP Score at Weeks 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field denotes that data was not planned to be collected and analyzed for the specified time-points in the respective groups. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240 and 264 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 0 and Week 48 of LTS11210: Campaign 1 X-ray Data - Participants From EFC11072 Part B | Baseline, Week 0 and 48 of LTS11210 | Analyzed on subset of participants who previously completed study EFC11072, Part B with end of treatment X-ray evaluation. Here, 'overall number of participants analyzed' = participants from studies EFC11072 Part B evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Sarilumab Monotherapy arm, as pre-specified in protocol. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 48 and Week 96 of LTS11210: Campaign 2 X-ray Data - Participants From EFC11072 Part B | Baseline, Week 48 and 96 of LTS11210 | Analyzed on subset of participants who previously completed study EFC11072, Part B with end of treatment X-ray evaluation. Here, 'overall number of participants analyzed' = participants from studies EFC11072 Part B evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Sarilumab Monotherapy arm, as pre-specified in protocol. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 96, Week 144 and Week 192 of LTS11210: Campaign 3 X-ray Data - Participants From EFC11072 Part B | Baseline, Week 96, 144 and 192 of LTS11210 | Analyzed on subset of participants who previously completed study EFC11072, Part B with end of treatment X-ray evaluation. Here, 'overall number of participants analyzed' = participants from studies EFC11072 Part B evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Sarilumab Monotherapy arm, as pre-specified in protocol. | score on scale | MEAN |
| SECONDARY | Percentage of Participants With no Radiographic Progression of the Van Der Heijde Modified Total Sharp Score at Week 0 and 48 of LTS11210: Campaign 1 X-ray Data - Participants From EFC11072 Part B | Week 0 (post-dose) and 48 of LTS11210 | Analyzed on subset of participants who previously completed study EFC11072, Part B with end of treatment X-ray evaluation. Here, 'overall number of participants analyzed' = participants from studies EFC11072 Part B evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Sarilumab Monotherapy arm, as pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With no Radiographic Progression of the Van Der Heijde Modified Total Sharp Score at Week 48 and Week 96 of LTS11210: Campaign 2 X-ray Data - Participants From EFC11072 Part B | Week 48 and 96 of LTS11210 | Analyzed on subset of participants who previously completed study EFC11072, Part B with end of treatment X-ray evaluation. Here, 'overall number of participants analyzed' = participants from studies EFC11072 Part B evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Sarilumab Monotherapy arm, as pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With no Radiographic Progression of the Van Der Heijde Modified Total Sharp Score at Week 96, 144 and 192 of LTS11210: Campaign 3 X-ray Data - Participants From EFC11072 Part B | Week 96, 144 and 192 of LTS11210 | Analyzed on subset of participants who previously completed study EFC11072, Part B with end of treatment X-ray evaluation. Here, 'overall number of participants analyzed' = participants from studies EFC11072 Part B evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Sarilumab Monotherapy arm, as pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Tender Joint Count (TJC) at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field denotes that data was not planned to be collected and analyzed for the specified time-points in the respective groups. | joints | MEAN |
| SECONDARY | Change From Baseline in Swollen Joint Count (SJC) at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Baseline, Week 0 (post-dose), 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480, 504 and 516 of LTS11210 | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category and 0 in the number analyzed field denotes that data was not planned to be collected and analyzed for the specified time-points in the respective groups. | joints | MEAN |
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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