Trial · NCT01114880
Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
NCT01114880, Phase 3, Completed, Abbott; results first posted 2011-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis. Trials, record NCT01114880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01114880
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
- NCT number
- NCT01114880
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 344 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Ankylosing Spondylitis
- Interventions
- adalimumab, placebo
- First posted
- 2010-05-03
- Last updated
- 2011-12-01
- Results first posted
- 2011-11-04
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | 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). |
| Secondary | Number of Participants Meeting the ASAS20 Response Criteria | Week 24 | 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). |
| Secondary | Number of Participants Meeting the ASAS40 Response Criteria | Week 12 | 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). |
| Secondary | Number of Participants Meeting the ASAS40 Response Criteria | Week 24 | 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). |
| Secondary | Number of Participants Meeting the ASAS5/6 Response Criteria | Week 12 | 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). |
| Secondary | Number of Participants Meeting the ASAS5/6 Response Criteria | Week 24 | 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). |
| Secondary | Number of Participants With ASAS Partial Remission | Week 12 | 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). |
| Secondary | Number of Participants With ASAS Partial Remission | Week 24 | 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). |
| Secondary | Change From Baseline in Patient Global Assessment of Disease Activity | Baseline and Week 12 | 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). |
| Secondary | Change From Baseline in Patient Global Assessment of Disease Activity | Baseline and Week 24 | 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). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | Week 12 | 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. | participants | NUMBER |
| SECONDARY | Number of Participants Meeting the ASAS20 Response Criteria | Week 24 | ITT analysis set, missing data imputed by NRI | participants | NUMBER |
| SECONDARY | Number of Participants Meeting the ASAS40 Response Criteria | Week 12 | ITT analysis set, missing data imputed by NRI | participants | NUMBER |
| SECONDARY | Number of Participants Meeting the ASAS40 Response Criteria | Week 24 | ITT analysis set, missing data imputed by NRI | participants | NUMBER |
| SECONDARY | Number of Participants Meeting the ASAS5/6 Response Criteria | Week 12 | ITT analysis set, missing data imputed by NRI | participants | NUMBER |
| SECONDARY | Number of Participants Meeting the ASAS5/6 Response Criteria | Week 24 | ITT analysis set, missing data imputed by NRI | participants | NUMBER |
| SECONDARY | Number of Participants With ASAS Partial Remission | Week 12 | ITT analysis set, missing data imputed by NRI | participants | NUMBER |
| SECONDARY | Number of Participants With ASAS Partial Remission | Week 24 | ITT analysis set, missing data imputed by NRI | participants | NUMBER |
| SECONDARY | Change From Baseline in Patient Global Assessment of Disease Activity | Baseline and Week 12 | ITT analysis set, missing data imputed by last observation carried forward (LOCF) | millimeters | MEAN |
| SECONDARY | Change From Baseline in Patient Global Assessment of Disease Activity | Baseline and Week 24 | ITT analysis set, missing data imputed by last observation carried forward (LOCF) | millimeters | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | Adalimumab/Adalimumab | 154 | participants | ||
| Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | Placebo/Adalimumab | 35 | participants | ||
| Number of Participants Meeting the ASAS20 Response Criteria | Adalimumab/Adalimumab | 180 | participants | ||
| Number of Participants Meeting the ASAS20 Response Criteria | Placebo/Adalimumab | 85 | participants | ||
| Number of Participants Meeting the ASAS40 Response Criteria | Adalimumab/Adalimumab | 102 | participants | ||
| Number of Participants Meeting the ASAS40 Response Criteria | Placebo/Adalimumab | 11 | participants | ||
| Number of Participants Meeting the ASAS40 Response Criteria | Adalimumab/Adalimumab | 134 | participants | ||
| Number of Participants Meeting the ASAS40 Response Criteria | Placebo/Adalimumab | 63 | participants | ||
| Number of Participants Meeting the ASAS5/6 Response Criteria | Adalimumab/Adalimumab | 128 | participants | ||
| Number of Participants Meeting the ASAS5/6 Response Criteria | Placebo/Adalimumab | 14 | participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Week 0 to Week 12) | STARTED | Adalimumab | 229 | |
| Period 1 (Week 0 to Week 12) | STARTED | Placebo | 115 | |
| Period 1 (Week 0 to Week 12) | COMPLETED | Adalimumab | 224 | |
| Period 1 (Week 0 to Week 12) | COMPLETED | Placebo | 113 | |
| Period 1 (Week 0 to Week 12) | NOT COMPLETED | Adalimumab | 5 | |
| Period 1 (Week 0 to Week 12) | NOT COMPLETED | Placebo | 2 | |
| Period 2 (Week 12 to Week 24) | STARTED | Adalimumab | 224 | |
| Period 2 (Week 12 to Week 24) | STARTED | Placebo | 113 | |
| Period 2 (Week 12 to Week 24) | COMPLETED | Adalimumab | 221 | |
| Period 2 (Week 12 to Week 24) | COMPLETED | Placebo | 111 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Adalimumab (Period 1) | 3 | 229 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo (Period 1) | 0 | 115 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Adalimumab/Adalimumab (Period 2) | 1 | 224 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo/Adalimumab (Period 2) | 0 | 113 | |
| other | Epigastric discomfort | Gastrointestinal disorders | Adalimumab (Period 1) | 3 | 229 | |
| other | Epigastric discomfort | Gastrointestinal disorders | Placebo (Period 1) | 0 | 115 | |
| other | Epigastric discomfort | Gastrointestinal disorders | Adalimumab/Adalimumab (Period 2) | 0 | 224 | |
| other | Epigastric discomfort | Gastrointestinal disorders | Placebo/Adalimumab (Period 2) | 0 | 113 | |
| other | Injection site erythema | General disorders | Adalimumab (Period 1) | 4 | 229 | |
| other | Injection site erythema | General disorders | Placebo (Period 1) | 0 | 115 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adalimumab (Period 1) | ||
| Total, all-cause mortality | Placebo (Period 1) | ||
| Total, all-cause mortality | Adalimumab/Adalimumab (Period 2) | ||
| Total, all-cause mortality | Placebo/Adalimumab (Period 2) | ||
| Total, other adverse events | Adalimumab (Period 1) | 55 | 229 |
| Total, other adverse events | Placebo (Period 1) | 16 | 115 |
| Total, other adverse events | Adalimumab/Adalimumab (Period 2) | 32 | 224 |
| Total, other adverse events | Placebo/Adalimumab (Period 2) | 22 | 113 |
| Total, serious adverse events | Adalimumab (Period 1) | 1 | 229 |
| Total, serious adverse events | Placebo (Period 1) | 1 | 115 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the ASAS5/6 Response Criteria | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the ASAS20 Response Criteria | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the ASAS40 Response Criteria | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants With ASAS Partial Remission | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the ASAS40 Response Criteria | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants With ASAS Partial Remission | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the ASAS5/6 Response Criteria | Trial comparisons |
| Adalimumab/Adalimumab vs Placebo/Adalimumab: Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01114880
GET https://conductscience.org/api/trials/v1/NCT01114880/registered?page=2