Trial · NCT03129100
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who do Not Experience a Flare | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) | Baseline, 2 Years | Ixekizumab structure population who have been treated with ixekizumab for at least 24 months. | Units on a Scale | MEAN |
| SECONDARY | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an ASAS40 Response | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units) | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Individual Components of the ASAS Criteria | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | milligram per liter (mg/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Chest Expansion in Centimeters | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | centimeter (cm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Occiput to Wall Distance | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with Baseline MASES score \>0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SPARCC score \>0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline TJC \>0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SJC \>0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Anterior Uveitis or Uveitis Flares | Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and regardless of history of anterior uveitis. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16) | Baseline, Week 64 | Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method. | units on a scale | LEAST_SQUARES_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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