Rheumatoid ArthritisPhase 4TREASURENCT01511003
A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)
A Phase 4 study testing Tacrolimus in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 4 sites in South Korea.
Trial summary
This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 5 Dec 2011to 11 May 2015
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria
- Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer
- Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL
- Subjects with ≥ 3 swollen joints out of 66 joints assessed
- Subjects with ≥ 6 tender joints out of 68 joints assessed
Who cannot join
- Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out
- Subjects with previous experience of tacrolimus (excluding external preparations)
- Subjects with renal dysfunction or with serum creatinin > 1.4 mg/dL at screening
- Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening
- Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c > 6.4% at screening
- Subjects complicated with hyperkalemia or with serum potassium level >5.5 mEq/L at screening
Show all 11Show fewer
- Subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications
- Subjects complicated with severe respiratory disease and infection
- Subjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.)
- Subjects who were treated with other investigational product(s) within 3 months before screening
- Other subjects who are considered ineligible for the study by the investigator
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Study site
Busan
Study site
Daejeon
Study site
Gyeonggi-do
Study site
Seoul
About this study
Official title: An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs
This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tacrolimus
- Keywords
- calcineurin inhibitor, Prograf, Rheumatoid arthritis (RA), Tacrolimus
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf
oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus group | Experimental | oral Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 response rate 6 months post dose
ACR20 is 20% improvement in ACR (American College of Rheumatology) core set
Measured: Baseline and 6 months post dose
Secondary outcomes (5)
ACR50 response rates at month 6
ACR50 is 50% improvement in ACR (American College of Rheumatology) core set
Measured: Baseline and at month 6
ACR70 response rates at month 6
ACR70 is 70% improvement in ACR (American College of Rheumatology) core set
Measured: Baseline and at month 6
Change in DAS28 from baseline to 6 months
DAS (Disease Activity Score in Rheumatoid Arthritis)
Measured: Baseline and at month 6
Change in bone loss rate from baseline to 6 months
comparative factors for bone loss rate: bone mineral densitometry [BMD], bone turnover marker test
Measured: Baseline and at month 6
Safety assessed by the incidence of adverse events, vital signs and lab-tests
Measured: For 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study start5 Dec 2011
- Primary completion11 May 2015
- Study completion11 May 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511003
- Sponsor's protocol ID
- PRGRA-10-04-KOR
- Acronym
- TREASURE
- Status last verified
- Aug 2018
- First submitted
- 4 Jan 2012
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs
- ClinicalTrials.gov ID
- NCT01511003
- Acronym / sponsor ID
- TREASURE / PRGRA-10-04-KOR
- Conditions
- Rheumatoid Arthritis
- Keywords
- calcineurin inhibitor, Prograf, Rheumatoid arthritis (RA), Tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- 5 Dec 2011 (actual)
- Primary completion
- 11 May 2015 (actual)
- Study completion
- 11 May 2015 (actual)
- First posted
- 18 Jan 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.
This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus group | Experimental | Drug: Tacrolimusoral |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria
- Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer
- Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL
- Subjects with ≥ 3 swollen joints out of 66 joints assessed
- Subjects with ≥ 6 tender joints out of 68 joints assessed
Key exclusion criteria (11 listed)
- Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out
- Subjects with previous experience of tacrolimus (excluding external preparations)
- Subjects with renal dysfunction or with serum creatinin > 1.4 mg/dL at screening
- Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening
- Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c > 6.4% at screening
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 |
|---|---|---|
| TacrolimusAlso: Prograforal | Drug | Tacrolimus group |
Primary outcome
ACR20 response rate 6 months post dose
Time frame: Baseline and 6 months post dose
ACR20 is 20% improvement in ACR (American College of Rheumatology) core set
5 secondary outcomes
ACR50 response rates at month 6
Time frame: Baseline and at month 6
ACR70 response rates at month 6
Time frame: Baseline and at month 6
Change in DAS28 from baseline to 6 months
Time frame: Baseline and at month 6
Change in bone loss rate from baseline to 6 months
Time frame: Baseline and at month 6
Safety assessed by the incidence of adverse events, vital signs and lab-tests
Time frame: For 6 months
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 13 Aug 2018.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Use Central Contact study chair
Astellas Pharma Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 4 sites in South Korea.
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 5 inclusion and 11 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
ACR20 response rate 6 months post dose (time frame: Baseline and 6 months post dose). 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 13 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.