Trial · NCT02605642
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) | During the observation period of 2 years | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | days | MEAN |
| PRIMARY | Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study | At Day 1 of 2 year observation period | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | months | MEDIAN |
| PRIMARY | Initial Dose of CT-P13 Infusion Administered to Participants | At Day 1 of 2 year observation period | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | milligram per kilogram | MEDIAN |
| PRIMARY | Number of Participants by Initial Frequency of CT-P13 Infusion Received | Baseline (Day 1) of 2 year observation period | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Total Dose of CT-P13 Infusion Received During Observation Period | During the observation period of 2 years | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | milligram per kilogram | MEDIAN |
| PRIMARY | Number of Participants With Change in CT-P13 Infusion Dose | During the observation period of 2 years | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) | During the observation period of 2 years | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | During the observation period of 2 years | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24 | Baseline, Months 6, 12, 18 and 24 | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for DAS28. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 | Baseline, Months 6, 12, 18 and 24 | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for DAS28. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 | Baseline, Weeks 6, 12, 18 and 24 | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASDAI. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 | Baseline, Weeks 6, 12, 18 and 24 | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for ASDAS. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 | Baseline, Weeks 6, 12, 18 and 24 | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASFI. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 | Baseline, Months 6, 12, 18 and 24 | Analysis performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of HAQ-DI. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24 | Baseline, Months 6, 12, 18 and 24 | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of EQ-5D-3L. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 | Baseline, Months 6, 12, 18 and 24 | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of EQ-5D-3L. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 | Baseline, Months 6, 12, 18 and 24 | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of SF-12v2. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 | Baseline, Months 6, 12, 18 and 24 | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of SF-12v2. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 | Baseline, Months 6, 12, 18 and 24 | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of PGA. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | millimeters | 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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