Trial · NCT01584388
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment | 6 months | The IgG4-RD RI is then calculated by adding the individual organ scores.At each assessment, the physician enters a 0-4 score after the organ/site listed with: 0 = Normal or resolved 1. = Improved but still present 2. = Persistent (still active; unchanged from previous visit) 3. = New or recurrent disease activity while patient is off treatment 4. = Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no) The Responder Index ranges from 0-60. |
| Primary | Cumulative Glucocorticoid Use at Baseline and 6 Months | 6 months | Cumulative glucocorticoid therapy between baseline and 6 months. |
| Primary | No Disease Flares During Rituximab Treatment Phase | Month 6 | Disease flare measured by responder Index score: At each assessment, the physician enters a 0-4 score after the organ/site listed with: 0 = Normal or resolved 1. = Improved but still present 2. = Persistent (still active; unchanged from previous visit) 3. = New or recurrent disease activity while patient is off treatment 4. = Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no) |
| Secondary | Retreatment With Rituximab for Disease Relapse | 12 months | Number of subjects that relapsed during the course of the trial |
| Secondary | Disease Response at 6 Months | 6 months | Decline of IgG4-RD Responder Index by at least two points for at least 6 months |
| Secondary | Sustained Disease Response | 12 months | Decline of the IgG4-RD RI by at least two points and maintained for 12 months. |
| Secondary | Complete Remission | 6 months | IgG4-RD RI (including serum IgG4) of 0 at six months |
| Secondary | Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months. | 6 months | IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months. |
| Secondary | Complete Remission at Any Timepoint | 12 months | IgG4-RD RI = 0 at any point in the trial |
| Secondary | Complete Remission (Any Timepoint), Exclusive of Serum IgG4 | 12 months | IgG4-RD RI = 0 (exclusive of serum IgG4) at any point in the trial |
| Secondary | Time to Disease Response | Mean days +/- standard deviation | Treatment phase up to 52 weeks (365 days) |
| Secondary | Time to Relapse | Days | Treatment phase up to 52 weeks (365 days) |
| Secondary | Time to Complete Remission | Days | Treatment phase up to 52 weeks (365 days) |
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/NCT01584388/registered