Ankylosing Spondylitis (AS)ADMITNCT03339089
Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases
An observational study of Ankylosing Spondylitis (AS) and Psoriasis, run by AbbVie at 10 sites in China.
Trial summary
The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ankylosing Spondylitis (AS), Psoriasis, Rheumatoid Arthritis (RA)
- How many people
- 224 participants
- Where
- 10 sitesChina
- Study dates
- 18 May 2018to 8 Jul 2021
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese participants diagnosed with rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis, for whom adalimumab (Humira®) treatment has already been decided as per local label, will be recruited from within the clinical setting of each rheumatologist or dermatologist participating in the study.
Who may be able to join
- Participants with a diagnosis of rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis
- Decision to initiate Humira® treatment in accordance with routine medical practice and in compliance with eligibility for adalimumab based on the local label
- Prior to any study-specific procedures, participant has voluntarily signed the authorization (or informed consent where applicable) to disclose and use anonymized personal health information after participate in this research.
Who cannot join
- Inadequate response to previous standard treatment with anti-tumor necrosis factor (TNF) biological agent according to the physician's clinical judgment.
- Participant has been treated with adalimumab within 70 days (five half-lives) prior to the Baseline Visit.
- Participants discontinued due to adverse drug reaction of previous adalimumab treatment.
- Participants who fulfill any of the contraindications as per adalimumab label in China.
- Participants, who in the clinician's view, may not be able to comply with the study requirements.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
The First affiliated hospital of chengdu medical university /ID# 210745
Chengdu, Sichuan, 610500
Sichuan Provincial orthopedic hospital /ID# 209341
Chengdu, 610041
West China Hospital, SCU West China School of Medicine, SCU /ID# 209333
Chengdu, 610041
Zhejiang Province People's Hospital /ID# 209342
Hangzhou, Zhejiang, 310014
Sir Run Run Shaw Hospital /ID# 210820
Hangzhou, Zhejiang, 310018
The First Hospital of Jiaxing /ID# 213686
Jiaxing, Zhejiang, 314000
The Second Hospital of Jiaxing /ID# 210744
Jiaxing, Zhejiang, 314033
Jinhua Municipal Central Hospital /ID# 209339
Jinhua, Zhejiang, 321000
AbbVie China /ID# 164373
Shanghai, Shanghai Municipality, 200041
Shenzhen Futian Hospital for rheumatic Diseases /ID# 209340
Shenzhen, Guangdong, 518040
About this study
The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
- Keywords
- rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, Immune-Mediated Inflammatory Diseases, Chinese Patients
- Medical subject headings
- Spondylitis, Ankylosing, Psoriasis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Rheumatoid Arthritis (RA) | This group/ cohort includes participants with RA. | |
| Participants with Plaque Psoriasis (Ps) | This group/ cohort includes participants with Ps. | |
| Participants with Ankylosing spondylitis (AS) | This group/ cohort includes participants with AS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24
The European quality of life-5 dimensions (EQ-5D) is a simple, easy to administer, standardized and self-report instrument for health status, which is applicable to a wide range of health conditions and treatment.
Measured: From Week 0 to Week 24
Secondary outcomes (13)
Assessing drug persistence
This is measured using drug survival rate.
Measured: Up to Week 52
Change from baseline in Healthcare Resource Utilization (HCRU)
This is assessed using the HCRU questionnaire.
Measured: From Week 0 to Week 52
Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Ankylosing spondylitis (AS)
WPAI questionnaire will be used to measure work absenteeism, work presenteeism, and daily activity impairment.
Measured: Up to Week 52
Change from Baseline in Dermatology Life Quality Index (DLQI) in participants with Psoriasis (Ps)
The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool in psoriasis clinical research.
Measured: Up to Week 52
Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Rheumatoid Arthritis (RA)
WPAI questionnaire will be used to measure work absenteeism, work presenteeism, and daily activity impairment.
Measured: Up to Week 52
Change from baseline in Clinical Disease Activity Index (CDAI) in participants with Rheumatoid Arthritis (RA)
The CDAI is used to evaluate disease activity.
Measured: Up to Week 52
Percentage of participants achieving low disease activity (CDAI 2.8-10) in participants with Rheumatoid Arthritis (RA)
The CDAI is used to evaluate disease activity.
Measured: Up to Week 52
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with Ankylosing spondylitis (AS)
BASDAI score is determined using a simple, self-reported questionnaire.
Measured: Up to Week 52
Percentage of participants achieving remission (CDAI<=2.8) in participants with Rheumatoid Arthritis (RA)
The CDAI is used to evaluate disease activity.
Measured: Up to Week 52
Change from baseline in EQ-5D Visual analog scale (VAS)
It is a patient-reported outcome (PRO) questionnaires used to assess quality of life (QoL).
Measured: From Week 0 to Week 52
Change from baseline in EQ-5D index score up to Week 52
The European quality of life-5 dimensions (EQ-5D) is a simple, easy to administer, standardized and self-report instrument for health status, which is applicable to a wide range of health conditions and treatment.
Measured: From Week 0 to Week 52
Proportion of participants achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in participants with Ankylosing spondylitis (AS)
BASDAI score is determined using a simple, self-reported questionnaire.
Measured: Up to Week 52
Change from baseline in Psoriasis Area and Severity Index (PASI) in participants with Psoriasis (Ps)
PASI provides a quantitative assessment of psoriasis disease state.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start18 May 2018
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339089
- Sponsor's protocol ID
- P16-828
- Acronym
- ADMIT
- Status last verified
- Jul 2022
- First submitted
- 8 Nov 2017
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT03339089
- Acronym / sponsor ID
- ADMIT / P16-828
- Keywords
- rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, Immune-Mediated Inflammatory Diseases, Chinese Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 May 2018 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 13 Nov 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.
The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with Rheumatoid Arthritis (RA) | – | –This group/ cohort includes participants with RA. |
| Participants with Plaque Psoriasis (Ps) | – | –This group/ cohort includes participants with Ps. |
| Participants with Ankylosing spondylitis (AS) | – | –This group/ cohort includes participants with AS. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese participants diagnosed with rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis, for whom adalimumab (Humira®) treatment has already been decided as per local label, will be recruited from within the clinical setting of each rheumatologist or dermatologist participating in the study.
Key inclusion criteria (3 listed)
- Participants with a diagnosis of rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis
- Decision to initiate Humira® treatment in accordance with routine medical practice and in compliance with eligibility for adalimumab based on the local label
- Prior to any study-specific procedures, participant has voluntarily signed the authorization (or informed consent where applicable) to disclose and use anonymized personal health information after participate in this research.
Key exclusion criteria (5 listed)
- Inadequate response to previous standard treatment with anti-tumor necrosis factor (TNF) biological agent according to the physician's clinical judgment.
- Participant has been treated with adalimumab within 70 days (five half-lives) prior to the Baseline Visit.
- Participants discontinued due to adverse drug reaction of previous adalimumab treatment.
- Participants who fulfill any of the contraindications as per adalimumab label in China.
- Participants, who in the clinician's view, may not be able to comply with the study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24
Time frame: From Week 0 to Week 24
The European quality of life-5 dimensions (EQ-5D) is a simple, easy to administer, standardized and self-report instrument for health status, which is applicable to a wide range of health conditions and treatment.
13 secondary outcomes
Assessing drug persistence
Time frame: Up to Week 52
Change from baseline in Healthcare Resource Utilization (HCRU)
Time frame: From Week 0 to Week 52
Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Ankylosing spondylitis (AS)
Time frame: Up to Week 52
Change from Baseline in Dermatology Life Quality Index (DLQI) in participants with Psoriasis (Ps)
Time frame: Up to Week 52
Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Rheumatoid Arthritis (RA)
Time frame: Up to Week 52
Change from baseline in Clinical Disease Activity Index (CDAI) in participants with Rheumatoid Arthritis (RA)
Time frame: Up to Week 52
Percentage of participants achieving low disease activity (CDAI 2.8-10) in participants with Rheumatoid Arthritis (RA)
Time frame: Up to Week 52
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with Ankylosing spondylitis (AS)
Time frame: Up to Week 52
Percentage of participants achieving remission (CDAI<=2.8) in participants with Rheumatoid Arthritis (RA)
Time frame: Up to Week 52
Change from baseline in EQ-5D Visual analog scale (VAS)
Time frame: From Week 0 to Week 52
Change from baseline in EQ-5D index score up to Week 52
Time frame: From Week 0 to Week 52
Proportion of participants achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in participants with Ankylosing spondylitis (AS)
Time frame: Up to Week 52
Change from baseline in Psoriasis Area and Severity Index (PASI) in participants with Psoriasis (Ps)
Time frame: Up to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
ABBVIE INC. study director
AbbVie
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis (AS) and Psoriasis, run by AbbVie at 10 sites 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 3 inclusion and 5 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
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?
Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24 (time frame: From Week 0 to Week 24). 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 8 Jul 2022.