Ankylosing SpondylitisPhase 4NCT02489760
Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
A Phase 4 study testing Adalimumab and Etanercept in people with Ankylosing Spondylitis, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Adalimumab and Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Oct 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.
- Stable background therapy as non-steroid anti-inflammatory for 2 weeks.
- Stable glucocorticoid for 4 weeks.
- Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.
- Stable anti-TNF biologics for 4 weeks.
- Written informed consent.
Who cannot join
- Serum creatinine ≥3.0 mg/dl.
- GPT≥5 times the laboratory's upper limit of normal.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.
Read the detailed description
This single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated Ankylosing Spondylitis(AS) patients.
Thirty patients will be enrolled and randomized equally into two arms.
Dosage and Administration：For standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.For half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Adalimumab, Etanercept
- Keywords
- Etanercept, Adalimumab, Ankylosing Spondylitis, Switch Study
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called Humira
The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
EtanerceptBiological
Also called Enbrel
The control arm will continue etanercept 25 mg subcutaneously twice a week
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab switch to Etanercept | Experimental | At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks. Receives: Biological: Adalimumab; Biological: Etanercept |
| Etanercept switch to Adalimumab | Experimental | At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks. Receives: Biological: Adalimumab; Biological: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath AS disease activity index (BASDAI)
The score of BASDAI on weeks 8
Measured: weeks 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2008
- Primary completionDec 2015
- Study completionOct 2016 (estimated)
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 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GCRC, Chung Shan Medical University
- Investigators
- Wei C- C, M.D., Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489760
- Sponsor's protocol ID
- CS08019
- Status last verified
- Jan 2016
- First submitted
- 27 Jun 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wei JC, Tsou HK, Leong PY, Chen CY, Huang JX. Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial. Front Med (Lausanne). 2020 Oct 30;7:566160. doi: 10.3389/fmed.2020.566160. eCollection 2020.
PubMed 33195311
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
- ClinicalTrials.gov ID
- NCT02489760
- Acronym / sponsor ID
- CS08019
- Conditions
- Ankylosing Spondylitis
- Keywords
- Etanercept, Adalimumab, Ankylosing Spondylitis, Switch Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Jul 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.
To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.
Detailed description
This single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated Ankylosing Spondylitis(AS) patients.
Thirty patients will be enrolled and randomized equally into two arms.
Dosage and Administration：For standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.For half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab switch to Etanercept | Experimental | Biological: Adalimumab, Biological: EtanerceptAt week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks. |
| Etanercept switch to Adalimumab | Experimental | Biological: Adalimumab, Biological: EtanerceptAt week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.
- Stable background therapy as non-steroid anti-inflammatory for 2 weeks.
- Stable glucocorticoid for 4 weeks.
- Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.
- Stable anti-TNF biologics for 4 weeks.
Key exclusion criteria (3 listed)
- Serum creatinine ≥3.0 mg/dl.
- GPT≥5 times the laboratory's upper limit of normal.
- Pregnant or breast-feeding women.
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 |
|---|---|---|
| AdalimumabAlso: HumiraThe treatment arm will receive adalimumab 40 mg subcutaneously biweekly | Biological | Adalimumab switch to Etanercept, Etanercept switch to Adalimumab |
| EtanerceptAlso: EnbrelThe control arm will continue etanercept 25 mg subcutaneously twice a week | Biological | Adalimumab switch to Etanercept, Etanercept switch to Adalimumab |
Primary outcome
Bath AS disease activity index (BASDAI)
Time frame: weeks 8
The score of BASDAI on weeks 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Derived from this study: PubMed 33195311Wei JC, Tsou HK, Leong PY, Chen CY, Huang JX. Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial. Front Med (Lausanne). 2020 Oct 30;7:566160. doi: 10.3389/fmed.2020.566160. eCollection 2020.
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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.
Wei C- C, M.D. study director
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab and Etanercept in people with Ankylosing Spondylitis, run by Chung Shan Medical University at 1 site in Taiwan.
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 6 inclusion and 3 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 Jan 2016. 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 Taiwan. 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 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?
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?
Bath AS disease activity index (BASDAI) (time frame: weeks 8). 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 NCT02489760, 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 20 Jan 2016.