Lung; Disease, Interstitial, With FibrosisPhase 2NCT03192657
Basiliximab Treating Interstitial Pneumonia of CADM
A Phase 2 study testing Basiliximab, Calcineurin Inhibitors and Steroids in people with Lung; Disease, Interstitial, With Fibrosis and Dermatomyositis, run by RenJi Hospital at 1 site in China.
Trial summary
This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung; Disease, Interstitial, With Fibrosis, Dermatomyositis
- What is being tested?
- Basiliximab, Calcineurin Inhibitors and Steroids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2017to Jun 2020
- 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
- Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.
- Agreement of contraception.
- Serum creatine Kinase ≤ 1.5 fold of upper normal level.
- Interstitial pneumonia:
- (meet at least two in four of following)
- interstitial pneumonia images in high resolution CT;
Show all 9Show fewer
- DLCO (diffusing capacity)≤ 60% predict in lung function test;
- elevated serum KL-6;
- serum anti-MDA5 (+).
Who cannot join
- Previous application of immunosuppressives or any target treatment for dermatomyositis.
- Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.
- Abnormal renal function at screening (serum creatine>300μmol/L，or eGFR<60mL/min/1.73m2, or end-stage renal disease).
- Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.
- History of any malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients
This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.
- Being tested
- Basiliximab, Calcineurin Inhibitors, Steroids
- Medical subject headings
- Disease, Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasiliximabDrug
The first administration should be within 8 weeks after disease onset.
Calcineurin InhibitorsDrug
Researchers can choose cyclosporin A or tacrolimus according to patient tolerance. Either agent should be applied promptly once infection is ruled out for a patient.
SteroidsDrug
Dosage of steroid can be adjusted according to personal experience of the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Basiliximab group | Experimental | 1. Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset.
2. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
3. Steroids: 1mg/kg/d, calculated with prednisone. Receives: Drug: Basiliximab; Drug: Calcineurin Inhibitors; Drug: Steroids |
| control group | Active comparator | 1. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
2. Steroids: 1mg/kg/d, calculated with prednisone. Receives: Drug: Calcineurin Inhibitors; Drug: Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 52 week
Secondary outcomes (6)
Forced vital capacity
measured with lung function test equipment
Measured: 52 week
Total lung capacity
measured with lung function test equipment
Measured: 52 week
Diffusing capacity
transfer factor of the lung for carbon monoxide, measured with lung function test equipment.
Measured: 52 week
Lung CT change
Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated.
Measured: 52 week
Serum ferritin
Measured: 52 week
Serum KL-6
A new biomarker of alveolar injury.
Measured: 52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study startJul 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung; Disease, Interstitial, With FibrosisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192657
- Sponsor's protocol ID
- ADM01
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients
- ClinicalTrials.gov ID
- NCT03192657
- Acronym / sponsor ID
- ADM01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 20 Jun 2017 (actual)
- 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 is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basiliximab group | Experimental | Drug: Basiliximab, Drug: Calcineurin Inhibitors, Drug: Steroids1. Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset. 2. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 3. Steroids: 1mg/kg/d, calculated with prednisone. |
| control group | Active comparator | Drug: Calcineurin Inhibitors, Drug: Steroids1. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 2. Steroids: 1mg/kg/d, calculated with prednisone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.
- Agreement of contraception.
- Serum creatine Kinase ≤ 1.5 fold of upper normal level.
- Interstitial pneumonia:
- (meet at least two in four of following)
Key exclusion criteria (6 listed)
- Previous application of immunosuppressives or any target treatment for dermatomyositis.
- Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.
- Abnormal renal function at screening (serum creatine>300μmol/L，or eGFR<60mL/min/1.73m2, or end-stage renal disease).
- Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.
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 |
|---|---|---|
| BasiliximabThe first administration should be within 8 weeks after disease onset. | Drug | Basiliximab group |
| Calcineurin InhibitorsResearchers can choose cyclosporin A or tacrolimus according to patient tolerance. Either agent should be applied promptly once infection is ruled out for a patient. | Drug | Basiliximab group, control group |
| SteroidsDosage of steroid can be adjusted according to personal experience of the researcher. | Drug | Basiliximab group, control group |
Primary outcome
Survival
Time frame: 52 week
6 secondary outcomes
Forced vital capacity
Time frame: 52 week
Total lung capacity
Time frame: 52 week
Diffusing capacity
Time frame: 52 week
Lung CT change
Time frame: 52 week
Serum ferritin
Time frame: 52 week
Serum KL-6
Time frame: 52 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Basiliximab, Calcineurin Inhibitors and Steroids in people with Lung; Disease, Interstitial, With Fibrosis and Dermatomyositis, run by RenJi Hospital at 1 site in China.
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
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?
Survival (time frame: 52 week). 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 20 Jun 2017.