Ankylosing SpondylitisPhase 3NCT01114880

Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

A Phase 3 study testing adalimumab in people with Ankylosing Spondylitis, run by Abbott at 9 sites in China.

Completed

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

Trial summary

Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs) Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Ankylosing Spondylitis
What is being tested?: adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 344 participants
Where: 9 sitesChina
Study dates: Jan 2010to Feb 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 through 65 years
Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria
Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits:
BASDAI score at least 4 cm
Total back pain on a visual analog scale (VAS) at least 40 mm
Morning stiffness at least 1 hr
Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as defined by the Investigator

Who cannot join

Has total spinal ankylosis (bamboo spine)
Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to Baseline
Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel disease) that is not clinically stable, as defined by the Investigator's best clinical judgment, for at least 28 days prior to Baseline
Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
Has prior exposure to any biologic therapy with potential therapeutic impact on AS, including anti-TNF (tumor necrosis factor) therapy

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

China9 sites

Site Reference ID/Investigator# 25522
Beijing, 100029
Site Reference ID/Investigator# 24055
Beijing, 100032
Site Reference ID/Investigator# 24052
Beijing, 100853
Site Reference ID/Investigator# 24056
Guangzhou, 510630
Site Reference ID/Investigator# 24243
Hangzhou, 310009
Site Reference ID/Investigator# 24054
Hefei, AN, 230022
Site Reference ID/Investigator# 24053
Shanghai, 200001
Site Reference ID/Investigator# 24058
Shanghai, 200003
Site Reference ID/Investigator# 24057
Xi'an, 710032

Other trials in China

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

Read the detailed description

Adults with active ankylosing spondylitis (AS) were randomized in a 2:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or matching placebo, given subcutaneously (SC), in the 12-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or matching placebo) at Week 0 and then eow until Week 10. Participants who completed the DB phase could enter the 12-week open-label (OL) phase, during which all participants received treatment with adalimumab 40 mg eow, starting at Weeks 12 through 22. No study drug was administered or injected at the final study visit (Week 24). A follow-up visit occurred 70 days after the last dose of study drug (in DB or OL phases) to obtain information on any ongoing or new adverse events (AEs).

Conditions: Ankylosing Spondylitis
Being tested: adalimumab, placebo
Keywords: ankylosing spondylitis, China
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 ABT-D2E7, Humira
Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week
placeboOther
Prefilled syringe, matching placebo administered subcutaneously every other week

Study groups in NCT01114880
Study group	Role	What they receive
Placebo	Placebo comparator	Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24. Receives: Biological: adalimumab; Other: placebo
Adalimumab	Experimental	Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24. Receives: Biological: adalimumab

What is being measured

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

Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Measured: Week 12

Secondary outcomes (21)

Number of Participants Meeting the ASAS20 Response Criteria
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Measured: Week 24
Number of Participants Meeting the ASAS40 Response Criteria
An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).
Measured: Week 12
Number of Participants Meeting the ASAS40 Response Criteria
An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).
Measured: Week 24
Number of Participants Meeting the ASAS5/6 Response Criteria
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).
Measured: Week 12
Number of Participants Meeting the ASAS5/6 Response Criteria
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).
Measured: Week 24
Number of Participants With ASAS Partial Remission
Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Measured: Week 12
Number of Participants With ASAS Partial Remission
Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).
Measured: Week 24
Change From Baseline in Patient Global Assessment of Disease Activity
Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).
Measured: Baseline and Week 12
Change From Baseline in Patient Global Assessment of Disease Activity
Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).
Measured: Baseline and Week 24
Change From Baseline in Total Back Pain Score
Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).
Measured: Baseline and Week 12
Change From Baseline in Total Back Pain Score
Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).
Measured: Baseline and Week 24
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Measured: Baseline and Week 12
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Measured: Baseline and Week 24
Change From Baseline in Inflammation Score
The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours.
Measured: Baseline and Week 12
Change From Baseline in Inflammation Score
The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours.
Measured: Baseline and Week 24
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2).
Measured: Week 12
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2).
Measured: Week 24
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.
Measured: Baseline and Week 12
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.
Measured: Baseline and Week 24
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Measured: Baseline and Week 12
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Measured: Baseline and Week 24

Timeline

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

Jan 2010Feb 2011

First posted3 May 2010 (estimated)
Study startJan 2010
Primary completionSep 2010
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01114880
Sponsor's protocol ID: M11-991
Status last verified: Nov 2011
First submitted: 5 Feb 2010
Last updated: 1 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ankylosing Spondylitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
ClinicalTrials.gov ID: NCT01114880
Acronym / sponsor ID: M11-991
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis, China
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 344 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Sep 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 3 May 2010 (estimated)
Results: Posted 4 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Biological: adalimumab, Other: placeboBlinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.
Adalimumab	Experimental	Biological: adalimumabBlinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 18 through 65 years
Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria
Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits:
Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as defined by the Investigator

Key exclusion criteria (5 listed)

Has total spinal ankylosis (bamboo spine)
Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to Baseline
Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel disease) that is not clinically stable, as defined by the Investigator's best clinical judgment, for at least 28 days prior to Baseline
Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
Has prior exposure to any biologic therapy with potential therapeutic impact on AS, including anti-TNF (tumor necrosis factor) therapy

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: ABT-D2E7, HumiraPrefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week	Biological	Adalimumab, Placebo
placeboPrefilled syringe, matching placebo administered subcutaneously every other week	Other	Placebo

Primary outcome

Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
Time frame: Week 12
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).

21 secondary outcomes

Number of Participants Meeting the ASAS20 Response Criteria
Time frame: Week 24
Number of Participants Meeting the ASAS40 Response Criteria
Time frame: Week 12
Number of Participants Meeting the ASAS40 Response Criteria
Time frame: Week 24
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 12
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 24
Number of Participants With ASAS Partial Remission
Time frame: Week 12
Number of Participants With ASAS Partial Remission
Time frame: Week 24
Change From Baseline in Patient Global Assessment of Disease Activity
Time frame: Baseline and Week 12
Change From Baseline in Patient Global Assessment of Disease Activity
Time frame: Baseline and Week 24
Change From Baseline in Total Back Pain Score
Time frame: Baseline and Week 12
Change From Baseline in Total Back Pain Score
Time frame: Baseline and Week 24
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Time frame: Baseline and Week 12
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Time frame: Baseline and Week 24
Change From Baseline in Inflammation Score
Time frame: Baseline and Week 12
Change From Baseline in Inflammation Score
Time frame: Baseline and Week 24
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
Time frame: Week 12
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
Time frame: Week 24
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Time frame: Baseline and Week 12
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Time frame: Baseline and Week 24
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
Time frame: Baseline and Week 12
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 4 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab	229	224
Placebo	115	113

Primary outcome: Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria

Time frame: Week 12. Number. Unit: participants

Measure	Adalimumab/Adalimumab n = 229	Placebo/Adalimumab n = 115
Value	154	35

Adalimumab/Adalimumab vs Placebo/Adalimumab: p < 0.001, Chi-squared

Population analysed: Analysis was performed on the Intent-to-Treat (ITT) analysis set, which included all subjects who were randomized and received at least 1 dose of double-blind study drug. A non-responder (NRI) imputation was used in which a missing response was imputed as non-response.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab (Period 1)	1 of 229 (0.4%)	55 of 229 (24%)	Not reported
Placebo (Period 1)	1 of 115 (0.9%)	16 of 115 (13.9%)	Not reported
Adalimumab/Adalimumab (Period 2)	3 of 224 (1.3%)	32 of 224 (14.3%)	Not reported
Placebo/Adalimumab (Period 2)	1 of 113 (0.9%)	22 of 113 (19.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Aileen Pangan study director

Abbott

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adalimumab in people with Ankylosing Spondylitis, run by Abbott at 9 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 7 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 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria (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 NCT01114880.

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 1 Dec 2011.