NCT04135508CompletedPhase 3
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
Bio-Thera Solutions0 sites554 target enrollmentStarted: December 13, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 554
- Primary Endpoint
- Assessment in SpondyloArthritis international Society (ASAS) 20
Study Overview
Brief Summary
A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
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®.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
BAT1406
Experimental
Adalimumab, 40 mg/0.8 mL/vial, subcutaneously 1 vial every two weeks, up to a maximum of 6 months treatment.
Intervention: BAT1406 (Drug)
Humira
Active Comparator
Adalimumab, 40 mg/0.8 mL/vial, subcutaneously 1 vial every two weeks, up to a maximum of 6 months treatment.
Intervention: Humira (Drug)
Outcomes
Primary Outcomes
Assessment in SpondyloArthritis international Society (ASAS) 20
Time Frame: week 12
the percentage of subjects achieving the Assessment in SpondyloArthritis international Society (ASAS) 20 treatment response
Secondary Outcomes
- Change of swollen and tender joint counts at week 12 and week 24 compared with baseline.(week 12; week 24)
- Percentage of subjects achieving ASAS20 treatment response(week 24)
- Percentage of subjects achieving ASAS40 treatment response(week 12; week 24)
- Percentage of subjects achieving ASAS5/6 treatment response(week 12; week 24)
- Percentage of subjects achieving BASDAI50 treatment response(week 12; week 24)
- Change of the performance status score compared with baseline(week 12; week 24)
- Change of the spinal pain score compared with baseline(week 12; week 24)
- Change of morning stiffness duration compared with baseline(week 12; week 24)
- Change of ASDAS compared with baseline(week 12; week 24)
- Change of BASDAI compared with baseline(week 12; week 24)
- Change of BASFI compared with baseline(week 12; week 24)
- Change of BASMI compared with baseline(week 12; week 24)
- Change of SF-36 compared with baseline(week 12; week 24)
- Change of EQ-5D compared with baseline(week 12; week 24)
- Change of chest expansion compared with baseline(week 12; week 24)
- Change of MASES compared with baseline(week 12; week 24)
Investigators
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