Rheumatoid ArthritisPhase 1NCT02499315
Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis
A Phase 1 study testing AMG 357 in people with Rheumatoid Arthritis, run by Amgen at 2 sites in United States.
Trial summary
The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- AMG 357
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Feb 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject provided informed consent.
- Rheumatoid arthritis present for ≥ 3 months.
- Global functional class I, II, or III.
- History of or positive for, Rheumatoid Arthritis
- Taking methotrexate consecutively for ≥ 12 weeks and on a stable dose at 10-25 mg weekly.
- Subjects currently taking NSAIDs or oral corticosteroids.
- Normal ECG values
- Immunizations up to date.
Who cannot join
- Positive Hepatitis B, Hepatitis C, Positive HIV
- Sensitivity to any of the products or components to be administered.
- Malignancy within 3 years
- Presence of recurrent or chronic infections
- Evidence of infections within the 30 days prior to randomization
- Presence of a serious infection
Show all 29Show fewer
- Prosthetic joint infection within 3 years or native joint infection within 1 year
- History of exposure to tuberculosis without a history of prophylactic treatment
- Class IV RA.
- Felty's syndrome
- Chronic pelvic pain or hemorrhagic ovarian cyst within 3 years
- Any bleeding disorder that is clinically significant
- Low white blood cell or neutrophil count
- Elevated serum creatinine clearance
- Low hemoglobin and platelet count
- Received live vaccines within 3 months of first dose
- Alcohol and/or substance abuse within past 12 months
- Blood donation within 60 days
- Positive urine screen for drugs of abuse
- Any prior use of rituximab in the last 6 months (or other B cell depleting agents) and CD19 levels < lower limits of normal
- Use of a weekly or bimonthly biologic within 2 weeks or monthly biologic agents within 4 weeks
- Corticosteroid injections for acute RA flare within 4 weeks
- Grapefruit juice or grapefruit containing products within 7 days of first dose.
- All herbal medicines, vitamins, and supplements within the 30 days
- The use of any experimental/investigational biologic DMARD unless off agent for 3 months; or off for 6 months for B cell depleting agents
- Known GI disease or GI procedures
- Women of reproductive potential who are unwilling to practice birth control
- Women who are pregnant/lactating/breastfeeding
- Subject with IgG levels < lower limit of normal at screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Dallas, Texas, 75231
Research Site
Duncansville, Pennsylvania, 16635
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis
The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- AMG 357, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 357Drug
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
PlaceboDrug
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| AMG 357 | Experimental | Not described Receives: Drug: AMG 357 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs
Measured: 1 year
Secondary outcomes (1)
AMG 357 pharmacokinetic profile (eg, plasma concentration, maximum observed concentration [Cmax], time at Cmax [Tmax], and area under the concentration-time curve [AUC])
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Study has stopped due to a decision by Amgen to terminate the program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
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
- NCT02499315
- Sponsor's protocol ID
- 20110247
- Status last verified
- May 2016
- First submitted
- 10 Apr 2015
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02499315
- Acronym / sponsor ID
- 20110247
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has stopped due to a decision by Amgen to terminate the program
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Jul 2015 (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.
The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 357 | Experimental | Drug: AMG 357 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject provided informed consent.
- Rheumatoid arthritis present for ≥ 3 months.
- Global functional class I, II, or III.
- History of or positive for, Rheumatoid Arthritis
- Taking methotrexate consecutively for ≥ 12 weeks and on a stable dose at 10-25 mg weekly.
Key exclusion criteria (29 listed)
- Positive Hepatitis B, Hepatitis C, Positive HIV
- Sensitivity to any of the products or components to be administered.
- Malignancy within 3 years
- Presence of recurrent or chronic infections
- Evidence of infections within the 30 days prior to randomization
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 357Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets. | Drug | AMG 357 |
| PlaceboOral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets. | Drug | Placebo |
Primary outcome
The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs
Time frame: 1 year
1 secondary outcome
AMG 357 pharmacokinetic profile (eg, plasma concentration, maximum observed concentration [Cmax], time at Cmax [Tmax], and area under the concentration-time curve [AUC])
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study has stopped due to a decision by Amgen to terminate the program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 357 in people with Rheumatoid Arthritis, run by Amgen at 2 sites in United States.
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 8 inclusion and 29 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: stopped early, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: Study has stopped due to a decision by Amgen to terminate the program). Results are not available in the source record.
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?
The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2016.