Trial · NCT01683695
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557. | 330 days, including a 21-day screening period | |
| Primary | Lupus Arthritis Response Rate | Day 169 | Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline |
| Secondary | Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group. | Day 169 | |
| Secondary | Percentage change in the tender and swollen joint counts at Day 169 relative to baseline. | Day 169 | |
| Secondary | Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline. | Days 85-169 | |
| Secondary | Proportion of subjects achieving reduction in and maintenance of prednisone (or its | Days 85-169 | |
| Secondary | Physician Global Assessment of Disease Activity (PGADA). | 330 days, including a 21-day screening period | |
| Secondary | Subject Global Assessment of Disease Activity (SGADA). | 330 days, including a 21-day screening period | |
| Secondary | Serum PK profile of AMG 557 after multiple dose administrations. | 330 days, including a 21-day screening period | |
| Secondary | Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects | Day 29 | |
| Secondary | Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169. | Day 85 to Day 169 |
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/NCT01683695/registered