Trial · NCT01544595
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | At week 68 (16 weeks after week 52) | The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders. |
| Secondary | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Week 52, 104, and 156 | Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab. PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement \[reduction\] in PASI score compared to baseline of the core study). PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders. PASI 100 response/remission: complete clearing of psoriasis (PASI=0) |
| Secondary | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region. |
| Secondary | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 52, 104, and 156 | The improvement (decrease from baseline) in PASI total scores observed at Week 52. Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included. |
| Secondary | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included. |
| Secondary | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Week 52 (baseline), 104, and 156 | Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions). Patients in the placebo groups were not evaluable after re-treatment with Secukinumab |
| Secondary | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) |
| Secondary | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline. |
| Secondary | Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period | Week 68 | Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52. time = 0 refers to Week 52 |
| Secondary | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | up to week 260 | PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52 |
| Secondary | Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse | up to week 260 | IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse. time = 0 refers to Week 52 |
| Secondary | Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period | up to week 156 | Time 0 = week 52 |
| Secondary | Percent of Participants With Relapse After Last Injection | up to week 16 | Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by \>50%. Time 0 = week 52 |
| Secondary | Percent of Participants With Rebound After Last Injection | up to week 68 | Rebound: PASI increases to \> 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of \> 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies. |
| Secondary | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data) | Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156 | Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment. |
| Secondary | Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period | Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156 | Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment. |
| Secondary | EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period | Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156 | EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. |
| Secondary | EQ-5D Health State Assessment (Observed Value) - Entire Study Period | week 64, 76, 88, 104, 116, 128, 140, and 156 | EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. |
| Secondary | Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period | Week 52-156 | CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal. IR=incidence rate per 100 subject years |
| Secondary | Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period | approximately 4 years | CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal. |
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
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