Ankylosing SpondylitisPhase 4NCT02638896
Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis
A Phase 4 study testing etanercept (Half-Dose), etanercept (Full-Dose) and Sulfasalazine in people with Ankylosing Spondylitis, run by Zhixiang Huang.
Trial summary
The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant clinical response. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- etanercept (Half-Dose), etanercept (Full-Dose) and Sulfasalazine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Apr 2017
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients 18 to 45 years of age.
- Proven AS according to the modified New York criteria
- Negative result of a pregnancy test in serum in screening visit and in urine in baseline visit, done in all women, except those surgically sterilized and those who have at least one year of menopause.
- Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception.
- ASDAS score ≥2.1
- Ability to reconstitute the drug and self-inject it or have a person who can do so.
- Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
- Ability to store injectable test article at 2º to 8º C.
Who cannot join
- Pregnancy/lactation.
- Previously exposure to murine or chimeric monoclonal antibodies.
- Receipt of any live (attenuated) vaccines within 4 weeks before screening visit.
- History of chronic or a recent serious infection.
- History of tuberculosis within the last 3 years.
- History of malignancy.
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- Significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection, central nervous system demyelinating events suggestive of multiple sclerosis.
- Presence or history of confirmed blood dyscrasias.
- History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening.
- Laboratory exclusions are: hemoglobin level < 8.5 mg/dl white blood cell count < 3.5×10e9/l, platelet count < 125 ×10e9/l, creatinine level > 175 mcmol/l, liver enzymes > 1.5 times the upper limit of normal or alkaline phosphatase > 2 times the upper limit of normal.
- Participation in trials of other investigational medications within 30 days of entering the study.
- Clinical examination showing significant abnormalities of clinical relevance.
- Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids.
- Hypersensitivity to any regent of study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing Spondylitis
The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant clinical response.
Read the detailed description
This single-centre, open-labeled randomized study will evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in patients who achieved a significant clinical response. AS patients who meet the inclusion criteria will take celecoxib (0.4g/d) during the whole period of study. In the first period, all patients will be given etanercept 50 mg subcutaneous injections weekly from baseline to week12. In the second period, patients who satisfied the criteria for disease remission will be randomized to one of the following three treatment arms: (1) Dose reduction arm: Patients will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. (2) Dose maintenance arm: Etanercept remains unchange from week12 to week24. (3) Etanercept discontinuation arm: Patients will be treated with sulfasalazine (2g/d) oral administration till week24. In the third period, all patients will take sulfasalazine (2g/d) till week 48. Ankylosing spondylitis disease activity score (ASDAS), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis functional index (BASFI), Bath ankylosing spondylitis metrology index (BASMI),Spondyloarthritis research consortium of Canada(SPARCC) score for the sacroiliac joint and adverse effect will be assessed in the study.
- Conditions
- Ankylosing Spondylitis
- Being tested
- etanercept (Half-Dose), etanercept (Full-Dose), Sulfasalazine, Celecoxib
- Keywords
- Ankylosing Spondylitis, Etanercept, Sulfasalazine, Efficacy, Safety, dose, reduction
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanercept (Half-Dose)Drug
Also called Enbrel
AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will be randomized to one of the three treatment arms. In the dose reduction arm, patients will receive etanercept 50 mg subcutaneous injections every other weeks .
etanercept (Full-Dose)Drug
Also called Enbrel
AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will be randomized to one of the three treatment arms. In the dose maintenance arm, patients will receive etanercept 50 mg subcutaneous injections every weeks.
SulfasalazineDrug
Also called Sulazine
AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will take sulfasalazine (2g/d) from week12 to week48.
CelecoxibDrug
Also called Celebrex
Celecoxib (0.4g/d) will be the background therapy.
| Study group | Role | What they receive |
|---|---|---|
| Dose reduction arm | Experimental | AS patients who achieved remission will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. Celecoxib will be the background therapy. Receives: Drug: etanercept (Half-Dose); Drug: Sulfasalazine; Drug: Celecoxib |
| Dose maintenance arm | Active comparator | AS patients who achieved remission will receive etanercept 50 mg subcutaneous injections every weeks plus sulfasalazine (2g/d) oral administration till week24. Celecoxib will be the background therapy. Receives: Drug: etanercept (Full-Dose); Drug: Sulfasalazine; Drug: Celecoxib |
| Etanercept discontinuation arm | Other | AS patients who achieved remission will take sulfasalazine (2g/d) till week24. Celecoxib will be the background therapy. Receives: Drug: Sulfasalazine; Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ASDAS from baseline to week48.
ASDAS includes CRP (mg/L); Apart from the value of CRP, the four additional self-reported items (rated on 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are calculated as follows: ASDAS= (0.121×total back pain) + (0.110×subject global) + (0.073×peripheral pain/swelling) + (0.058×duration of morning stiffness) + (0.579×Ln(CRP+1)).
Measured: Baseline, Week12, Week24, Week48
Secondary outcomes (6)
Change in ESR from baseline to week48.
ESR is a laboratory test that provides a non-specific measure of inflammation. This test assesses the rate at which red blood cells fall in a test tube and is measured in mm/h. Normal range is 0 to 30 mm/h. A higher rate is consistent with inflammation.
Measured: Baseline, Week12, Week24, Week48
Change in CRP from baseline to week48.
CRP is a marker of inflammation and measured in mg/L. A higher level is consistent with inflammation.
Measured: Baseline, Week12, Week24, Week48
Change in BASFI from baseline to Week48.
BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS patients and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10).
Measured: Baseline, Week12, Week24, Week48
Change in BASMI from baseline to Week48.
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Measured: Baseline, Week12, Week24, Week48
Change in SPARCC score for the sacroiliac joint from baseline to Week48.
SPARCC score for the sacroiliac joint was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.
Measured: Baseline, Week12, Week24, Week48
Percentage of participants with serious adverse events (SAEs) or adverse events (AEs) by co-morbidity from baseline to Week48.
Any untoward medical occurrence in a participant who received study regents was considered an AE, without regard to possibility of relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline, Week12, Week24, Week48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhixiang Huang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zhixiang Huang, Health and Family Planning Commission of Guangdong
- Investigators
- Tianwang Li, MD, Principal investigator, Guangdong No.2 Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638896
- Sponsor's protocol ID
- 2015117183344589
- Status last verified
- Dec 2015
- First submitted
- 20 Dec 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02638896
- Acronym / sponsor ID
- 2015117183344589
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Etanercept, Sulfasalazine, Efficacy, Safety, dose, reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhixiang HuangOther government
- Study start
- Jan 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 23 Dec 2015 (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.
The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant clinical response.
Detailed description
This single-centre, open-labeled randomized study will evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in patients who achieved a significant clinical response. AS patients who meet the inclusion criteria will take celecoxib (0.4g/d) during the whole period of study. In the first period, all patients will be given etanercept 50 mg subcutaneous injections weekly from baseline to week12. In the second period, patients who satisfied the criteria for disease remission will be randomized to one of the following three treatment arms: (1) Dose reduction arm: Patients will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. (2) Dose maintenance arm: Etanercept remains unchange from week12 to week24. (3) Etanercept discontinuation arm: Patients will be treated with sulfasalazine (2g/d) oral administration till week24. In the third period, all patients will take sulfasalazine (2g/d) till week 48. Ankylosing spondylitis disease activity score (ASDAS), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis functional index (BASFI), Bath ankylosing spondylitis metrology index (BASMI),Spondyloarthritis research consortium of Canada(SPARCC) score for the sacroiliac joint and adverse effect will be assessed in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose reduction arm | Experimental | Drug: etanercept (Half-Dose), Drug: Sulfasalazine, Drug: CelecoxibAS patients who achieved remission will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. Celecoxib will be the background therapy. |
| Dose maintenance arm | Active comparator | Drug: etanercept (Full-Dose), Drug: Sulfasalazine, Drug: CelecoxibAS patients who achieved remission will receive etanercept 50 mg subcutaneous injections every weeks plus sulfasalazine (2g/d) oral administration till week24. Celecoxib will be the background therapy. |
| Etanercept discontinuation arm | Other | Drug: Sulfasalazine, Drug: CelecoxibAS patients who achieved remission will take sulfasalazine (2g/d) till week24. Celecoxib will be the background therapy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients 18 to 45 years of age.
- Proven AS according to the modified New York criteria
- Negative result of a pregnancy test in serum in screening visit and in urine in baseline visit, done in all women, except those surgically sterilized and those who have at least one year of menopause.
- Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception.
- ASDAS score ≥2.1
Key exclusion criteria (14 listed)
- Pregnancy/lactation.
- Previously exposure to murine or chimeric monoclonal antibodies.
- Receipt of any live (attenuated) vaccines within 4 weeks before screening visit.
- History of chronic or a recent serious infection.
- History of tuberculosis within the last 3 years.
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 |
|---|---|---|
| etanercept (Half-Dose)Also: EnbrelAS patients who satisfied the criteria for disease remission (ASDAS<1.3) will be randomized to one of the three treatment arms. In the dose reduction arm, patients will receive etanercept 50 mg subcutaneous injections every other weeks . | Drug | Dose reduction arm |
| etanercept (Full-Dose)Also: EnbrelAS patients who satisfied the criteria for disease remission (ASDAS<1.3) will be randomized to one of the three treatment arms. In the dose maintenance arm, patients will receive etanercept 50 mg subcutaneous injections every weeks. | Drug | Dose maintenance arm |
| SulfasalazineAlso: SulazineAS patients who satisfied the criteria for disease remission (ASDAS<1.3) will take sulfasalazine (2g/d) from week12 to week48. | Drug | Dose maintenance arm, Dose reduction arm, Etanercept discontinuation arm |
| CelecoxibAlso: CelebrexCelecoxib (0.4g/d) will be the background therapy. | Drug | Dose maintenance arm, Dose reduction arm, Etanercept discontinuation arm |
Primary outcome
Change in ASDAS from baseline to week48.
Time frame: Baseline, Week12, Week24, Week48
ASDAS includes CRP (mg/L); Apart from the value of CRP, the four additional self-reported items (rated on 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are calculated as follows: ASDAS= (0.121×total back pain) + (0.110×subject global) + (0.073×peripheral pain/swelling) + (0.058×duration of morning stiffness) + (0.579×Ln(CRP+1)).
6 secondary outcomes
Change in ESR from baseline to week48.
Time frame: Baseline, Week12, Week24, Week48
Change in CRP from baseline to week48.
Time frame: Baseline, Week12, Week24, Week48
Change in BASFI from baseline to Week48.
Time frame: Baseline, Week12, Week24, Week48
Change in BASMI from baseline to Week48.
Time frame: Baseline, Week12, Week24, Week48
Change in SPARCC score for the sacroiliac joint from baseline to Week48.
Time frame: Baseline, Week12, Week24, Week48
Percentage of participants with serious adverse events (SAEs) or adverse events (AEs) by co-morbidity from baseline to Week48.
Time frame: Baseline, Week12, Week24, Week48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
- Individual participant dataSharing planned: No
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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.
Tianwang Li, MD principal investigator
Guangdong No.2 Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etanercept (Half-Dose), etanercept (Full-Dose) and Sulfasalazine in people with Ankylosing Spondylitis, run by Zhixiang Huang.
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 8 inclusion and 14 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 28 Dec 2015. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhixiang Huang, MD (86-20-89169091, huang-zhix@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ASDAS from baseline to week48. (time frame: Baseline, Week12, Week24, Week48). 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 28 Dec 2015.