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Ankylosing SpondylitisPhase 3NCT04135508

A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira

A Phase 3 study testing BAT1406 and Humira in people with Ankylosing Spondylitis, run by Bio-Thera Solutions.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
BAT1406 and Humira
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
554 participants
Where
No sites listed yet
Study dates
13 Dec 2016to 31 May 2018
Phase
Phase 3
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 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Subjects have used any biological products to treat AS within 6 months prior to the enrollment.
  • Clinical or imaging studies suggested that the spine has reached complete rigidity (if there were two consecutive lumbar vertebrae not fused together, then the spine has not reached complete rigidity).
  • Allergic to any ingredients of Humira, allergic to human proteins or susceptible to immunoglobulin allergies.
  • Subjects with a medical history of hepatitis B, hepatitis C, HIV, any immunodeficiency, or with a positive laboratory test result (hepatitis B surface antigen, hepatitis C antibody, or HIV antibody) during screening.
  • Subjects diagnosed with active pulmonary tuberculosis, latent tuberculosis infection, or subjects suspected of tuberculosis based on clinical manifestations (including but not limited to pulmonary tuberculosis).
  • Subjects with positive T.SPOT.TB test or abnormalities in tuberculosis-related chest X-ray; or subjects with TB who have not received standard treatment of at least 30 days.
Show all 27Show fewer
  • Active infections, including acute and chronic infections, and local infections (such as sepsis, abscesses, opportunistic infections, and invasive fungal infections).
  • Subjects who have taken oral antibiotics within 2 weeks prior to the screening or have been given intramuscular/intravenous treatments for infection within 4 weeks prior to the screening, or have had severe infections within 6 months prior to the screening (investigators must determine the potential risks of subjects' enrollment based on the individual's clinical history).
  • Subjects with a history of recurrent herpes zoster, history of Listeria infection, reticuloendotheliosis, and other chronic or recurrent infections.
  • Subjects who have undergone ostectomy/arthrectomy/synovectomy within 3 months prior to the screening, or planned to undergo joint or spinal surgery during the trial.
  • Subjects with clinically significant laboratory abnormalities that suggested the presence of unknown disease and required further clinical examination.
  • Subjects with an apparent history of drug abuse or alcohol dependence at present or in the past 2 years.
  • Subjects with one or more of the following diseases:
  • Subjects without self-care ability, those who require wheelchairs or those who are bedridden;
  • Uncontrolled hypertension (defined as systolic pressure >150 mmHg, or diastolic pressure >100 mmHg during the screening period);
  • Subjects with a history of congestive heart failure (New York Heart Association classification III/IV);
  • Subjects with a history of acute myocardial infarction or unstable angina within 12 months prior to the screening;
  • Subjects with serious arrhythmias;
  • Any subject with clinically significant respiratory diseases, including but not limited to chronic obstructive pulmonary disease, asthma, interstitial lung disease, bronchiectasis, and pleural effusion;
  • Subjects with a history of demyelinating diseases or with symptoms suggestive of such diseases, including but not limited to: multiple sclerosis and Guillain-Barré syndrome;
  • Subjects who had not used a stable dose of medication to control diabetes within 4 weeks prior to the screening (glycated hemoglobin HbA1c >7% during screening);
  • h.Subjects with any arthritis or rheumatic diseases (in addition to AS) that may affect the evaluation of the clinical study, including but not limited to: rheumatoid arthritis, osteoarthritis, psoriatic arthritis, systemic lupus erythematosus, gouty arthritis, and fibromyalgia; j.Subjects with any neurological, psychotic, or other systemic diseases that may affect the clinical efficacy evaluation; k.Subjects who have had a history of malignancy in the past 5 years (except for non-metastatic squamous cell carcinoma or basal cell carcinoma or cervical carcinoma in situ that have been cured); l.History of lymphoma or lymphoproliferative diseases.
  • Subjects using the following concomitant drugs:
  • Have used alkylating preparations within 12 months prior to the screening.
  • Injected corticosteroids into the joint cavity, muscle or vein within 4 weeks prior to screening.
  • Subjects who have participated in other clinical trials within 3 months prior to the enrollment or planned to participate in other clinical trials.
  • The investigator determined that the subject was not suitable for this trial.

About this study

Official title: A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial Parallel Controlled With Humira to Evaluate the Efficacy and Safety of BAT1406 Injection in the Treatment of Ankylosing Spondylitis

A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira

Read the detailed description

This is a multicenter, randomized, double-blind, active comparator, parallel two arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1406 to Humira® in patients with active ankylosing spondylitis (AS) to demonstrate clinical equivalence of BAT1406 and Humira®.

Being tested
BAT1406, Humira
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAT1406Drug

    Also called No Other Intervention Names

    40mg/0.8ml

  • HumiraDrug

    Also called Adalimumab

    40mg/0.8ml

Study groups in NCT04135508
Study groupRoleWhat they receive
BAT1406ExperimentalAdalimumab, 40 mg/0.8 mL/vial, subcutaneously 1 vial every two weeks, up to a maximum of 6 months treatment.
Receives: Drug: BAT1406
HumiraActive comparatorAdalimumab, 40 mg/0.8 mL/vial, subcutaneously 1 vial every two weeks, up to a maximum of 6 months treatment.
Receives: Drug: Humira

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment in SpondyloArthritis international Society (ASAS) 20

    the percentage of subjects achieving the Assessment in SpondyloArthritis international Society (ASAS) 20 treatment response

    Measured: week 12

Secondary outcomes (16)

  1. Percentage of subjects achieving ASAS20 treatment response

    the percentage of subjects achieving the Assessment in SpondyloArthritis international Society (ASAS) 20 treatment response

    Measured: week 24

  2. Percentage of subjects achieving ASAS40 treatment response

    the percentage of subjects achieving the Assessment in SpondyloArthritis international Society (ASAS) 40 treatment response

    Measured: week 12; week 24

  3. Percentage of subjects achieving ASAS5/6 treatment response

    the percentage of subjects achieving ASAS5/6 treatment response

    Measured: week 12; week 24

  4. Percentage of subjects achieving BASDAI50 treatment response

    the percentage of subjects achieving BASDAI50 treatment response

    Measured: week 12; week 24

  5. Change of the performance status score compared with baseline

    The performance status is used for measuring and evaluating disease activity in Ankylosing Spondylitis

    Measured: week 12; week 24

  6. Change of the spinal pain score compared with baseline

    the spinal pain is used for measuring and evaluating disease pain in Ankylosing Spondylitis

    Measured: week 12; week 24

  7. Change of morning stiffness duration compared with baseline

    The morning stiffness duration is used for measuring and evaluating disease activity in Ankylosing Spondylitis

    Measured: week 12; week 24

  8. Change of ASDAS compared with baseline

    The ASDAS is used for measuring and evaluating disease activity in Ankylosing Spondylitis

    Measured: week 12; week 24

  9. Change of BASDAI compared with baseline

    The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis

    Measured: week 12; week 24

  10. Change of BASFI compared with baseline

    The BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 10 cm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 10 (impossible).

    Measured: week 12; week 24

  11. Change of BASMI compared with baseline

    The BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis

    Measured: week 12; week 24

  12. Change of SF-36 compared with baseline

    SF-36 survey will be used to calculate overall, mental (MCS) and physical (PCS) component scores at week 12; week 24 compared to baseline

    Measured: week 12; week 24

  13. Change of EQ-5D compared with baseline

    EQ-5D is a standard instrument to measure of health status

    Measured: week 12; week 24

  14. Change of chest expansion compared with baseline

    Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.

    Measured: week 12; week 24

  15. Change of MASES compared with baseline

    The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.

    Measured: week 12; week 24

  16. Change of swollen and tender joint counts at week 12 and week 24 compared with baseline.

    Measured: week 12; week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2019
  2. Study start13 Dec 2016
  3. Primary completion22 Mar 2018
  4. Study completion31 May 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04135508
Sponsor's protocol ID
BAT-1406-003-CR
Status last verified
Oct 2019
First submitted
17 Oct 2019
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BAT1406 and Humira in people with Ankylosing Spondylitis, run by Bio-Thera Solutions.

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 0 inclusion and 27 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 2019. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Assessment in SpondyloArthritis international Society (ASAS) 20 (time frame: week 12). 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 NCT04135508.

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 2019.

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