Rheumatoid ArthritisPhase 2NCT01285752
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
A Phase 2 study testing AK106-001616 and Active comparator in people with Rheumatoid Arthritis, run by Asahi Kasei Therapeutics Corporation at 26 sites in 7 countries.
Trial summary
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- AK106-001616 and Active comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 26 sitesin 7 countries
- Study dates
- Feb 2011to Dec 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA (class I to III)
- Stable dose of methotrexate (at least 12 weeks)
Who cannot join
- Pregnant or breastfeeding
- Abnormal screening laboratory test values considered to be clinically significant
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
Ukraine6 sites
Study site
Donetsk
Study site
Kharkiv
Study site
Kyiv
Study site
Ternopil
Study site
Vinnytsa
Study site
Zaporizhzhya
Czechia5 sites
Study site
Hlučín
Study site
Hostivice
Study site
Prague
Study site
Uherské Hradiště
Study site
Zlín
Poland5 sites
Study site
Bialystok
Study site
Elblag
Study site
Lublin
Study site
Poznan
Study site
Warsaw
About this study
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- AK106-001616, Active comparator
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK106-001616Drug
AK106-001616Drug
Active comparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AK106-001616 |
| 2 | Experimental | Not described Receives: Drug: AK106-001616 |
| 3 | Active comparator | Not described Receives: Drug: Active comparator |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionDec 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285752
- Sponsor's protocol ID
- AK106 II-02
- Status last verified
- Apr 2012
- First submitted
- 27 Jan 2011
- Last updated
- 25 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT01285752
- Acronym / sponsor ID
- AK106 II-02
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2011 (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.
To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AK106-001616 |
| 2 | Experimental | Drug: AK106-001616 |
| 3 | Active comparator | Drug: Active comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of RA (class I to III)
- Stable dose of methotrexate (at least 12 weeks)
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding
- Abnormal screening laboratory test values considered to be clinically significant
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 |
|---|---|---|
| AK106-001616 | Drug | 1 |
| AK106-001616 | Drug | 2 |
| Active comparator | Drug | 3 |
Primary outcome
Not reported in the source record.
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 25 Jul 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.
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK106-001616 and Active comparator in people with Rheumatoid Arthritis, run by Asahi Kasei Therapeutics Corporation at 26 sites in 7 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 2 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Ukraine, Czechia, Poland, Germany, Hungary and 2 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.
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 25 Jul 2016.