Rheumatoid ArthritisPhase 1NCT02052375
A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate
A Phase 1 study testing ASP2408 in people with Rheumatoid Arthritis and Pharmacokinetics of ASP2408, run by Astellas Pharma Global Development, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2408. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis, Pharmacokinetics of ASP2408
- What is being tested?
- ASP2408
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Dec 2013
- 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
- Subject weighs at least 50 kg.
- Subject has a body mass index (BMI) of ≤ 35 kg/m2.
- Subject's 12-lead electrocardiogram (ECG) results are normal at Screening and Day 1 prior to study drug dosing or, if abnormal, the abnormality is not clinically significant as determined by the Investigator.
- Subject has Rheumatoid Arthritis (RA) that was diagnosed according to the 1987 revised criteria of the American College of Rheumatology (ACR) ≥ 6 months prior to Screening.
- Subject meets the ACR 1991 revised criteria for Global Functional Status in RA, Class I, II or III at Screening.
- Subject MUST be on concomitant methotrexate (MTX):
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- for ≥ 3 months prior to Day 1, AND
- at a stable dose (10 - 25 mg/week) for ≥ 28 days prior to Day 1 and throughout the study.
- Subject's other related medications taken for the treatment of RA at the time of Screening must meet the noted stability requirements and remain on a stable regimen, as follows:
- Non-steroidal anti-inflammatory drugs (NSAIDs), selective cyclooxy-genase-2 (COX-2) inhibitors, oral corticosteroids (≤ 10 mg of prednisone, or equivalent, daily) or low dose opioids (≤ 30 mg of oral morphine, or equivalent, daily) must be stable for ≥ 28 days prior to Screening and remain so throughout the Treatment and Observation Period.
- Hydroxychloroquine (Plaquenil®) and sulfasalazine must have started ≥ 2 months, and be stable for ≥ 28 days, prior to Day 1.
Who cannot join
- Subject has an ongoing infection or has had an infection requiring intravenous antibiotics within 1 month prior to Day 1.
- Subject has a past history of serious opportunistic infection.
- Subject has a positive Mantoux tuberculin skin or QuantiFERON-TB Gold test within 90 days of, or at Screening, and has not completed an adequate course of antimicrobial therapy per CDC guidelines.
- Subject received any live or live-attenuated vaccine within 30 days prior to Day 1.
- Subject received any of the following:
- Anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 60 days prior to Day 1.
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- Rituximab (Rituxan®) or any other anti-CD20 antibody within 180 days prior to Day 1.
- Leflunomide (Arava®) within 60 days prior to drug dosing on Day 1, unless the subject has undergone cholestyramine washout at least 30 days prior to Day 1.
- Oral or injectable gold, azathioprine, penicillamine, cyclosporine, or tacrolimus within 30 days prior to Day 1.
- Cyclophosphamide within 180 days prior to Day 1.
- Subject has received any CTLA4-Ig molecule (including, but not limited to abatacept [Orencia®] and belatacept [Nulojix]).
- Subject has participated in a previous clinical study with treatment with ASP2408 or ASP2409 or has participated in another dose cohort of the current trial.
- Subject has previously participated in any interventional clinical study, or has received an experimental agent within 56 days or 5 half-lives, whichever is longer, prior to Day 1.
- Subject has a history of prolonged QT syndrome.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Metroplex Clinical Research Center, LLC
Dallas, Texas, 75231
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2408.
Read the detailed description
This is an ascending dose frequency study. There are two cohorts of active and placebo patients. The first cohort is dosed every 4 weeks for a total of 3 doses. The second cohort is dosed every two weeks for a total of 3 doses.
- Conditions
- Rheumatoid Arthritis, Pharmacokinetics of ASP2408
- Being tested
- ASP2408, Placebo
- Keywords
- Rheumatoid Arthritis, ASP2408, methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2408Drug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| ASP2408 low dosing frequency | Experimental | Not described Receives: Drug: ASP2408 |
| ASP2408 high dosing frequency | Experimental | Not described Receives: Drug: ASP2408 |
| Placebo low dosing frequency | Experimental | Not described Receives: Drug: Placebo |
| Placebo high dosing frequency | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of ASP2408: AUCtau
Area Under the Concentration-Time curve for a dosing interval (AUCtau)
Measured: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacokinetic parameter of ASP2408: Cmax
Maximum Concentration (Cmax)
Measured: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacokinetic parameter of ASP2408: Tmax
Time to Attain Cmax (Tmax)
Measured: Days 1, 2 ,3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacokinetic parameter of ASP2408: Ctrough
Trough Concentration (Ctrough)
Measured: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Safety assessed by adverse events (AEs), laboratory tests, electrocardiograms (ECGs), physical examinations, pulse oximetry, vital signs and Anti-ASP2408 antibody (ADA) formulation
Measured: Up to 1 year
Secondary outcomes (2)
Composite of pharmacokinetics of ASP2408: t1/2, Vz/F, CL/F,
Apparent Terminal Elimination Half-life (t1/2), Volume of distribution (Vz/F), Apparent Body Clearance (CL/F)
Measured: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacodynamic parameter of ASP2408: CD86 receptor occupancy
Cluster of Differentiation 86, a co-stimulatory ligand on antigen-presenting cells; alternate notation for B7.2 (CD86)
Measured: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22,36, 38, 43, 50, 57, 66, 71, 72, 78, 85,113, 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
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 Astellas Pharma Global Development, Inc.The 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052375
- Sponsor's protocol ID
- 2408-CL-0201
- Status last verified
- Feb 2014
- First submitted
- 30 Jan 2014
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate
- ClinicalTrials.gov ID
- NCT02052375
- Acronym / sponsor ID
- 2408-CL-0201
- Conditions
- Rheumatoid Arthritis, Pharmacokinetics of ASP2408
- Keywords
- Rheumatoid Arthritis, ASP2408, methotrexate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Feb 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.
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2408.
Detailed description
This is an ascending dose frequency study. There are two cohorts of active and placebo patients. The first cohort is dosed every 4 weeks for a total of 3 doses. The second cohort is dosed every two weeks for a total of 3 doses.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP2408 low dosing frequency | Experimental | Drug: ASP2408 |
| ASP2408 high dosing frequency | Experimental | Drug: ASP2408 |
| Placebo low dosing frequency | Experimental | Drug: Placebo |
| Placebo high dosing frequency | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject weighs at least 50 kg.
- Subject has a body mass index (BMI) of ≤ 35 kg/m2.
- Subject's 12-lead electrocardiogram (ECG) results are normal at Screening and Day 1 prior to study drug dosing or, if abnormal, the abnormality is not clinically significant as determined by the Investigator.
- Subject has Rheumatoid Arthritis (RA) that was diagnosed according to the 1987 revised criteria of the American College of Rheumatology (ACR) ≥ 6 months prior to Screening.
- Subject meets the ACR 1991 revised criteria for Global Functional Status in RA, Class I, II or III at Screening.
Key exclusion criteria (14 listed)
- Subject has an ongoing infection or has had an infection requiring intravenous antibiotics within 1 month prior to Day 1.
- Subject has a past history of serious opportunistic infection.
- Subject has a positive Mantoux tuberculin skin or QuantiFERON-TB Gold test within 90 days of, or at Screening, and has not completed an adequate course of antimicrobial therapy per CDC guidelines.
- Subject received any live or live-attenuated vaccine within 30 days prior to Day 1.
- Subject received any of the following:
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 |
|---|---|---|
| ASP2408subcutaneous injection | Drug | ASP2408 high dosing frequency, ASP2408 low dosing frequency |
| Placebosubcutaneous injection | Drug | Placebo high dosing frequency, Placebo low dosing frequency |
Primary outcome
Pharmacokinetic parameter of ASP2408: AUCtau
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Area Under the Concentration-Time curve for a dosing interval (AUCtau)
Pharmacokinetic parameter of ASP2408: Cmax
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Maximum Concentration (Cmax)
Pharmacokinetic parameter of ASP2408: Tmax
Time frame: Days 1, 2 ,3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Time to Attain Cmax (Tmax)
Pharmacokinetic parameter of ASP2408: Ctrough
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Trough Concentration (Ctrough)
Safety assessed by adverse events (AEs), laboratory tests, electrocardiograms (ECGs), physical examinations, pulse oximetry, vital signs and Anti-ASP2408 antibody (ADA) formulation
Time frame: Up to 1 year
2 secondary outcomes
Composite of pharmacokinetics of ASP2408: t1/2, Vz/F, CL/F,
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141
Pharmacodynamic parameter of ASP2408: CD86 receptor occupancy
Time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22,36, 38, 43, 50, 57, 66, 71, 72, 78, 85,113, 141
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 6 Feb 2014.
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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.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
3 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 ASP2408 in people with Rheumatoid Arthritis and Pharmacokinetics of ASP2408, run by Astellas Pharma Global Development, Inc. at 3 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 11 inclusion and 14 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Pharmacokinetic parameter of ASP2408: AUCtau (time frame: Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141). The study lists 5 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 6 Feb 2014.