Interstitial Pneumonia Associated With Polymyositis/DermatomyositisNCT02159651
A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia
An observational study of Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
- What is being tested?
- tacrolimus
- Type of treatment
- Pill or oral medicine
- How many people
- 179 participants
- Where
- 8 sitesJapan
- Study dates
- 1 Apr 2014to 23 Dec 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with interstitial pneumonia associated with polymyositis/dermatomyositis who treated with Prograf
Who may be able to join
- Hospitalized patient
- Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kanto
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.
- Being tested
- tacrolimus
- Keywords
- tacrolimus, interstitial pneumonia, prograf
- Medical subject headings
- Dermatomyositis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called FK506, Prograf
oral
| Study group | Role | What they receive |
|---|---|---|
| 1: Dermatomyositis group | patients with interstitial pneumonia associated with dermatomyositis Receives: Drug: tacrolimus | |
| 2: Polymyositis group | patients with interstitial pneumonia associated with polymyositis Receives: Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to three years
Secondary outcomes (6)
Respiratory function test value (%FVC, %DLco)
Respiratory function is evaluated by % FVC ( percent-predicted forced vital capacity) amd %DLco (diffusion capacity of CO).
Measured: Up to three years
Arterial blood gas analysis value (PaO2, AaDO2)
Arterial blood gas analysis by PaO2 (arterial O2 pressure) and AaDO2 (alveolar-arterial oxygen difference)
Measured: Up to three years
Chest CT findings
CT: computed tomography
Measured: Up to three years
Serum KL-6 value (serum SP-D value)
KL-6 (sialylated carbohydrate antigen KL-6) and SP-D (surfactant protein D) are used as marker of interstitial pneumonia
Measured: Up to three years
Patient disposition
patient disposition includes 1)number of case report forms collected, 2)number of patients analyzed for safety, 3)number of patients analysed for efficacy
Measured: Up to three years
Safety assessed by the incidence of adverse events
Any adverse events which include adverse events leading to death, white blood cell count, erythrocyte sedimentation rate and other abnormal findings from laboratory tests
Measured: Up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study start1 Apr 2014
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
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 Interstitial Pneumonia Associated With Polymyositis/DermatomyositisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159651
- Sponsor's protocol ID
- PRGI01
- Other IDs
- 506-MA-PRGI-01
- Status last verified
- Apr 2020
- First submitted
- 6 Jun 2014
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Kuwana M, Wakasugi N, Furuya T, Uno S, Suda T. Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan. J Rheumatol. 2022 Jul;49(7):707-718. doi: 10.3899/jrheum.210322. Epub 2022 Apr 15.
PubMed 35428708
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
- ClinicalTrials.gov ID
- NCT02159651
- Acronym / sponsor ID
- PRGI01
- Keywords
- tacrolimus, interstitial pneumonia, prograf
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 10 Jun 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 study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Dermatomyositis group | – | Drug: tacrolimuspatients with interstitial pneumonia associated with dermatomyositis |
| 2: Polymyositis group | – | Drug: tacrolimuspatients with interstitial pneumonia associated with polymyositis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with interstitial pneumonia associated with polymyositis/dermatomyositis who treated with Prograf
Key inclusion criteria (2 listed)
- Hospitalized patient
- Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis
Key exclusion criteria (0 listed)
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: FK506, Prograforal | Drug | 1: Dermatomyositis group, 2: Polymyositis group |
Primary outcome
Overall survival
Time frame: Up to three years
6 secondary outcomes
Respiratory function test value (%FVC, %DLco)
Time frame: Up to three years
Arterial blood gas analysis value (PaO2, AaDO2)
Time frame: Up to three years
Chest CT findings
Time frame: Up to three years
Serum KL-6 value (serum SP-D value)
Time frame: Up to three years
Patient disposition
Time frame: Up to three years
Safety assessed by the incidence of adverse events
Time frame: Up to three 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 22 Oct 2024.
- Derived from this study: PubMed 35428708Kuwana M, Wakasugi N, Furuya T, Uno S, Suda T. Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan. J Rheumatol. 2022 Jul;49(7):707-718. doi: 10.3899/jrheum.210322. Epub 2022 Apr 15.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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.
Medical Director study director
Astellas Pharma Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis, run by Astellas Pharma Inc at 8 sites in Japan.
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 0 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 22 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 8 sites in Japan. 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.
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?
Overall survival (time frame: Up to three 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 NCT02159651, 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 22 Oct 2024.