Trial · NCT01683695
Safety Study of AMG 557 in Subjects With Lupus Arthritis
NCT01683695, Phase 1, Completed, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of AMG 557 in Subjects With Lupus Arthritis. Trials, record NCT01683695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01683695
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of AMG 557 in Subjects With Lupus Arthritis
- NCT number
- NCT01683695
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Lupus Arthritis, Systemic Lupus Erythematosus
- Interventions
- AMG 557, Matching Placebo
- First posted
- 2012-09-12
- Last updated
- 2017-01-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29513931 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01683695
GET https://conductscience.org/api/trials/v1/NCT01683695/registered