Trial · NCT00076752
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse-free Complete Clinical Response | 60 months | Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later. |
| Secondary | Number of Participants With Adverse Events | 18 months | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Anti-Nuclear Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU. |
| Secondary | Extractable Nuclear Antigen (ENA) | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19. |
| Secondary | Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU. |
| Secondary | Anti-Smith-Ribonuclear Protein Antibody | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years. | Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU. |
| Secondary | White Blood Cells | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL. |
| Secondary | Absolute Neutrophil Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL. |
| Secondary | Absolute Lymphocyte Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL. |
| Secondary | Platelet Count | Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years. | The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL. |
| Secondary | Cluster of Differentiation 3 (CD3) + Cells | Day 0, 1 month, 3 months, 6 months, 1 year and 2 years. | The CD3+Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 650-2108 uL. |
| Secondary | Cluster of Differentiation 4 (CD4) + Cells | Day 0, 1 month, 3 months, 6 months, 1 year and 2 years. | The CD4 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 358-1259 uL. |
| Secondary | Cluster of Differentiation 8 (CD8) + Cells | Day 0, 1 month, 3 months, 6 months, 1 year and 2 years. | The CD8 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 194-836 u/L. |
| Secondary | Cluster of Differentiation 19 (CD19) + Cells | Day 0, 1 month, 3 months, 6 months, 1 year and 2 years. | The CD19 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 47-409 u/L. |
| Secondary | Natural Killer Cells | Day 0, 1 month, 3 months, 6 months, 1 year and 2 years. | The natural killer cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 87-505 uL. |
| Secondary | Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) | Day -7, day 0, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years and 3 years. | The SLEDAI activity index test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a SLEDAI score of ≤3; partial response is at least 50% improvement in general disease activity as measured by SLEDAI. Remission is a SLEDAI score \<3 and prednisone \<10mg/day. 6+ indicates active disease requiring therapy. A score of 0 indicates a better outcome and a score greater then 6+ indicates a worse outcome. |
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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