Arthritis, RheumatoidPhase 2NCT01711814
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
A Phase 2 study testing peficitinib in people with Arthritis, Rheumatoid, run by Astellas Pharma Global Development, Inc. at 51 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- peficitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 51 sitesin 8 countries
- Study dates
- 26 Sep 2012to 25 Mar 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject completed the week 12 visit in one of the Phase 2, ASP015K Rheumatoid Arthritis studies within the previous 14 days.
- Male and Female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation
Who cannot join
- Subject has any condition considered by the Principal Investigator or Medical Monitor to preclude adequate evaluation of drug safety
- Subject is scheduled to receive any investigational drug other than ASP015K during the course of the study
- Subject is scheduled to receive a prohibited medication
- Subject has a planned major surgery
- Subject discontinued study drug due to meeting study drug discontinuation criteria prior to completion of the Week 12 visit in the preceding study or fulfills study drug discontinuation criteria at the final study visit of the preceding study
- Subject has out of range laboratory values within 14 days of the Day 1 study dosing
- Absolute lymphocyte count (ALC) < 500/mm3
- Creatine Phosphokinase (CPK) > 1.5 x upper limit of normal unless the level has been stable for at least 2 consecutive blood draws (at least 7 days apart), and subject does not have symptoms of muscle aching, weakness, or severe unusual muscle cramps
Trial locations and contacts
51 sites in 8 countries.
51 sites in 8 countries
United States20 sites
Site US3319
Austin, Texas, 78705
Site US3218
Birmingham, Alabama, 35216
Site US3327
Chesapeake, Virginia, 23320
Site US3320
Clarksburg, West Virginia, 26301
Site US3331
Colorado Springs, Colorado, 80920
Site US345
Duncansville, Pennsylvania, 16635
Site US3329
Elizabethtown, Kentucky, 42701
Site US3298
Hickory, North Carolina, 28602
Site US1894
Jacksonville, Florida, 32216
Site US3306
Knoxville, Tennessee, 37909
Site US828
La Jolla, California, 92093-0943
Site US702
Morton Grove, Illinois, 60053
Site US3300
Oklahoma City, Oklahoma, 73103
Site US3232
Orlando, Florida, 32804
Site US3227
Palm Desert, California, 92260
Site US219
Palo Alto, California, 94304
Site US3332
Santa Maria, California, 93454
Site US3226
Vernon Hills, Illinois, 60061
Site US291
Wheaton, Maryland, 20902
Site US3304
Wyomissing, Pennsylvania, 19610
Poland7 sites
Site PL3233
Bialystok, Polska, 15-351
Site PL3391
Bialystok, 15-879
Site PL2893
Bydgoszcz, 85-168
Site PL3603
Krakow, 31-637
Site PL3601
Lublin, 20-582
Site PL3600
Warsaw, 02-118
Site PL3599
Warsaw, 02-653
Hungary6 sites
Site HU3461
Balatonfüred, 8230
Site HU3398
Békéscsaba, 5600
Site HU3302
Budapest, 1027
Site HU3448
Budapest, 1027
Site HU3462
Budapest, 1027
Site HU3447
Debrecen, H-4043
Colombia5 sites
Site CO3326
Barranquilla, Atlantico
Site CO3297
Bogotá
Site CO2826
Bucamaranga
Site CO3450
Bucaramanga
Site CO3451
Cali
Czechia4 sites
Site CZ3388
Prague, 128 50
Site CZ3376
Praha-Nusle, 140 00
Site CZ3225
Uherské Hradiště, 68601
Site CZ3449
Zlín, 760 01
Mexico4 sites
Site MX3238
Guadalajara, 44650
Site MX3307
Guadalajara, Jalisco, 44280
Site MX3310
México, 6700
Site MX3317
Morelia, 58070
Bulgaria3 sites
Site BG3613
Burgas, 8000
Site BG3217
Plovdiv, 4003
Site BG3303
Sofia, 1612
About this study
Official title: A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study.
Read the detailed description
This study is comprised of a 104 week treatment period beginning on Day 1 of study drug administration and a 30-day follow-up period or permanent termination of clinical development of the product, whichever is earlier.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- peficitinib
- Keywords
- Rheumatoid Arthritis, ASP015K
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peficitinibDrug
Also called ASP015K
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP015K | Experimental | Experimental Receives: Drug: peficitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by recording of adverse events and clinical laboratory evaluations
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study start26 Sep 2012
- Primary completion25 Mar 2016
- Study completion25 Mar 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 Arthritis, RheumatoidStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711814
- Sponsor's protocol ID
- 015K-CL-RA25
- Other IDs
- 2011-006021-23
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2012
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Genovese MC, Greenwald MW, Gutierrez-Urena SR, Cardiel MH, Poiley JE, Zubrzycka-Sienkiewicz A, Codding CE, Wang A, He W, Amos R, Vinueza R, Wang X, Garg JP, Kivitz AJ. Two-Year Safety and Effectiveness of Peficitinib in Moderate-To-Severe Rheumatoid Arthritis: A Phase IIb, Open-Label Extension Study. Rheumatol Ther. 2019 Dec;6(4):503-520. doi: 10.1007/s40744-019-00167-6. Epub 2019 Aug 13.
PubMed 31410787
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
- ClinicalTrials.gov ID
- NCT01711814
- Acronym / sponsor ID
- 015K-CL-RA25
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, ASP015K
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Study start
- 26 Sep 2012 (actual)
- Primary completion
- 25 Mar 2016 (actual)
- Study completion
- 25 Mar 2016 (actual)
- First posted
- 22 Oct 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.
The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study.
Detailed description
This study is comprised of a 104 week treatment period beginning on Day 1 of study drug administration and a 30-day follow-up period or permanent termination of clinical development of the product, whichever is earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP015K | Experimental | Drug: peficitinibExperimental |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject completed the week 12 visit in one of the Phase 2, ASP015K Rheumatoid Arthritis studies within the previous 14 days.
- Male and Female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation
Key exclusion criteria (8 listed)
- Subject has any condition considered by the Principal Investigator or Medical Monitor to preclude adequate evaluation of drug safety
- Subject is scheduled to receive any investigational drug other than ASP015K during the course of the study
- Subject is scheduled to receive a prohibited medication
- Subject has a planned major surgery
- Subject discontinued study drug due to meeting study drug discontinuation criteria prior to completion of the Week 12 visit in the preceding study or fulfills study drug discontinuation criteria at the final study visit of the preceding 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 |
|---|---|---|
| peficitinibAlso: ASP015Koral | Drug | ASP015K |
Primary outcome
Safety assessed by recording of adverse events and clinical laboratory evaluations
Time frame: 2 years
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 Oct 2024.
- Derived from this study: PubMed 31410787Genovese MC, Greenwald MW, Gutierrez-Urena SR, Cardiel MH, Poiley JE, Zubrzycka-Sienkiewicz A, Codding CE, Wang A, He W, Amos R, Vinueza R, Wang X, Garg JP, Kivitz AJ. Two-Year Safety and Effectiveness of Peficitinib in Moderate-To-Severe Rheumatoid Arthritis: A Phase IIb, Open-Label Extension Study. Rheumatol Ther. 2019 Dec;6(4):503-520. doi: 10.1007/s40744-019-00167-6. Epub 2019 Aug 13.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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
51 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peficitinib in people with Arthritis, Rheumatoid, run by Astellas Pharma Global Development, Inc. at 51 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 2 inclusion and 8 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Poland, Hungary, Colombia, Czechia 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety assessed by recording of adverse events and clinical laboratory evaluations (time frame: 2 years). 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 NCT01711814, 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 21 Oct 2024.