Lupus Arthritis, Systemic Lupus ErythematosusPhase 1NCT01683695
Safety Study of AMG 557 in Subjects With Lupus Arthritis
A Phase 1 study testing AMG 557 in people with Lupus Arthritis, Systemic Lupus Erythematosus, run by Amgen at 13 sites in 8 countries.
Trial summary
This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Arthritis, Systemic Lupus Erythematosus
- What is being tested?
- AMG 557
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 13 sitesin 8 countries
- Study dates
- Jun 2012to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
- Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;
- Other inclusion criteria may apply.
Who cannot join
- Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
- Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
- Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
- Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
- Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
- Other exclusion criteria may apply
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
United States4 sites
Research Site
Danbury, Connecticut, 06810
Research Site
Los Angeles, California, 90048
Research Site
Manhasset, New York, 11030
Research Site
San Leandro, California, 94578
Malaysia2 sites
Research Site
Kuala Lumpur, Kuala Lumpur, 59100
Research Site
Kuching, Sarawak, 93586
United Kingdom2 sites
Research Site
Birmingham, B18 7QH
Research Site
London, WC1E 6JF
About this study
Official title: A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis
This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.
- Being tested
- AMG 557, Matching Placebo
- Keywords
- Lupus Arthritis, Systemic Lupus Erythematosus, AMG 557, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 557Drug
AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Matching PlaceboDrug
Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
| Study group | Role | What they receive |
|---|---|---|
| AMG 557 | Active comparator | All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155. Receives: Drug: AMG 557 |
| AMG 557 Matching Placebo | Placebo comparator | All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.
Measured: 330 days, including a 21-day screening period
Lupus Arthritis Response Rate
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
Measured: Day 169
Secondary outcomes (9)
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.
Measured: Day 169
Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.
Measured: Day 169
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.
Measured: Days 85-169
Proportion of subjects achieving reduction in and maintenance of prednisone (or its
Measured: Days 85-169
Physician Global Assessment of Disease Activity (PGADA).
Measured: 330 days, including a 21-day screening period
Subject Global Assessment of Disease Activity (SGADA).
Measured: 330 days, including a 21-day screening period
Serum PK profile of AMG 557 after multiple dose administrations.
Measured: 330 days, including a 21-day screening period
Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects
Measured: Day 29
Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.
Measured: Day 85 to Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus Arthritis, Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683695
- Sponsor's protocol ID
- 20101103
- Status last verified
- Jan 2017
- First submitted
- 14 Mar 2012
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25.
PubMed 29513931
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis
- ClinicalTrials.gov ID
- NCT01683695
- Acronym / sponsor ID
- 20101103
- Keywords
- Lupus Arthritis, Systemic Lupus Erythematosus, AMG 557, Lupus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 557 | Active comparator | Drug: AMG 557All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155. |
| AMG 557 Matching Placebo | Placebo comparator | Drug: Matching PlaceboAll will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
- Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;
- Other inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
- Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
- Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
- Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
- Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 557AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects. | Drug | AMG 557 |
| Matching PlaceboPlacebo will be administered as subcutaneous injections in the anterior abdomen of the subjects. | Drug | AMG 557 Matching Placebo |
Primary outcome
Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.
Time frame: 330 days, including a 21-day screening period
Lupus Arthritis Response Rate
Time frame: 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
9 secondary outcomes
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.
Time frame: Day 169
Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.
Time frame: Day 169
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.
Time frame: Days 85-169
Proportion of subjects achieving reduction in and maintenance of prednisone (or its
Time frame: Days 85-169
Physician Global Assessment of Disease Activity (PGADA).
Time frame: 330 days, including a 21-day screening period
Subject Global Assessment of Disease Activity (SGADA).
Time frame: 330 days, including a 21-day screening period
Serum PK profile of AMG 557 after multiple dose administrations.
Time frame: 330 days, including a 21-day screening period
Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects
Time frame: Day 29
Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.
Time frame: Day 85 to Day 169
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Derived from this study: PubMed 29513931Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 557 in people with Lupus Arthritis, Systemic Lupus Erythematosus, run by Amgen at 13 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Malaysia, United Kingdom, Australia, Denmark and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557. (time frame: 330 days, including a 21-day screening period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.