Rheumatoid ArthritisPhase 1NCT02277574
Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
A Phase 1 study testing AMP-110 in people with Rheumatoid Arthritis, run by MedImmune LLC at 7 sites in United States.
Trial summary
This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- AMP-110
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2014to Jul 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be able to provide written informed consent
- Body mass index 18.5 to 35.0 kg/m2
- Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
- Global Functional Class I, II, or III according to ACR 1991 revised criteria
- Must have at least 4 tender joints and 4 swollen joints (28-joint assesssment)
- Use of >/= 1 non-steroidal anti-inflammatory drugs is allowed, subject must be on a stable dose for >/= 2 weeks prior to randomization
- Use of >/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for >/= 3 months and a stable dose for >/= 6 weeks prior to randomization
- Stable use of low dose oral corticosteroids (</= 10 mg prednisone per day or equivalent) is allowed; subjects must be on a stable dose for >/= 4 weeks prior to randomization
Who cannot join
- Prior to Day 0, use of:
- Rituximab within 6 months
- Abatacept within 3 months
- Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
- Etanercept, Anakinra, immunoglobulin or blood products within 28 days
- Prior immunotherapy, including high dose oral corticosteroids or systemic corticosteroids such as prednisone, biologics, Janus kinase (JAK) inhibitors, such as tofacitinib or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer
Show all 15Show fewer
- Prior exposure to T cell depleting agents such as Campath (alemtuzumab)
- Evidence of any active or recent infection
- History of systemic autoimmune disease other than Rheumatoid Arthritis; secondary Sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of RA allowed
- History of allergic reactions
- History of anaphylaxis or allergic diathesis
- Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
- Evidence of active or latent tuberculosis
- Vaccination with live attenuated viruses within the 2 weeks prior to Day 0
- Pregnant or breastfeeding women
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Metroplex Clinical Research Center
Dallas, Texas, 75231
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arthritis Treatment Center
Frederick, Maryland, 21702
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
Omega Research Consultants, LLC.
Orlando, Florida, 32804
Arthritis Center, Inc.
Palm Harbor, Florida, 34684
About this study
Official title: A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- AMP-110, Placebo
- Keywords
- Rheumatoid arthritis, Arthritis, Joint diseases, Musculoskeletal diseases
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMP-110Biological
2, 5, or 10 mg/kg
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Crossover Group 1 | Experimental | Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo Receives: Biological: AMP-110 |
| Crossover Group 2 | Experimental | Subjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo
Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations
Measured: From start of study drug administration through Day 112
Repeat dose pharmacokinetic parameters of AMP-110 in serum
Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life
Measured: From start of study drug administration through Day 112
Secondary outcomes (1)
Optimal dose for repeat dosing of AMP-110
Optimal dose will be determined through the occurrence of AEs, SAEs, ACR-20 and DAS-28 results, and individual AMP-110 concentrations in serum including peak and trough levels
Measured: From start of study drug administration through Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJul 2015
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.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277574
- Sponsor's protocol ID
- AMP-110-02
- Status last verified
- Nov 2016
- First submitted
- 23 Jul 2014
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02277574
- Acronym / sponsor ID
- AMP-110-02
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Arthritis, Joint diseases, Musculoskeletal diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Oct 2014 (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 Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossover Group 1 | Experimental | Biological: AMP-110Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo |
| Crossover Group 2 | Experimental | Other: PlaceboSubjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be able to provide written informed consent
- Body mass index 18.5 to 35.0 kg/m2
- Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
- Global Functional Class I, II, or III according to ACR 1991 revised criteria
- Must have at least 4 tender joints and 4 swollen joints (28-joint assesssment)
Key exclusion criteria (15 listed)
- Prior to Day 0, use of:
- Evidence of any active or recent infection
- History of systemic autoimmune disease other than Rheumatoid Arthritis; secondary Sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of RA allowed
- History of allergic reactions
- History of anaphylaxis or allergic diathesis
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 |
|---|---|---|
| AMP-1102, 5, or 10 mg/kg | Biological | Crossover Group 1 |
| PlaceboPlacebo | Other | Crossover Group 2 |
Primary outcome
Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo
Time frame: From start of study drug administration through Day 112
Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations
Repeat dose pharmacokinetic parameters of AMP-110 in serum
Time frame: From start of study drug administration through Day 112
Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life
1 secondary outcome
Optimal dose for repeat dosing of AMP-110
Time frame: From start of study drug administration through Day 112
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 21 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 AMP-110 in people with Rheumatoid Arthritis, run by MedImmune LLC at 7 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 15 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo (time frame: From start of study drug administration through Day 112). 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?
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 21 Nov 2016.