Trial · NCT01166282
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
NCT01166282, Phase 3, Completed, AbbVie (prior sponsor, Abbott); results first posted 2016-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis. Trials, record NCT01166282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01166282
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
- NCT number
- NCT01166282
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 46 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
- Enthesitis Related Arthritis (ERA)
- Interventions
- adalimumab, placebo for adalimumab
- First posted
- 2010-07-21
- Last updated
- 2021-07-12
- Other registries' IDs
- eudract:2009-017938-46
- Results first posted
- 2016-06-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 | Baseline and Week 12 | A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data. |
| Secondary | Number of Sites of Enthesitis: Change From Baseline to Week 12 | Baseline and Week 12 | The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. |
| Secondary | Tender Joint Count (TJC72): Change From Baseline to Week 12 | Baseline and Week 12 | Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. |
| Secondary | Swollen Joint Count (SJC68): Change From Baseline to Week 12 | Baseline and Week 12 | Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. |
| Secondary | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30) | Baseline and Week 12 | The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with \>30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data. |
| Secondary | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50) | Baseline and Week 12 | The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with \>30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used. |
| Secondary | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70) | Baseline and Week 12 | The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with \>30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used. |
| Secondary | Number of Participants With Adverse Events (AEs) | Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks) | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either probably related to study drug, possibly related to study drug, probably not related, or not related to study drug. For more details on adverse events please see the AE section below. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 | Baseline and Week 12 | ITT population | percent change | MEAN |
| SECONDARY | Number of Sites of Enthesitis: Change From Baseline to Week 12 | Baseline and Week 12 | ITT population | sites of enthesitis | MEAN |
| SECONDARY | Tender Joint Count (TJC72): Change From Baseline to Week 12 | Baseline and Week 12 | ITT population | units on a scale | MEAN |
| SECONDARY | Swollen Joint Count (SJC68): Change From Baseline to Week 12 | Baseline and Week 12 | ITT population | units on a scale | MEAN |
| SECONDARY | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30) | Baseline and Week 12 | ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50) | Baseline and Week 12 | ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70) | Baseline and Week 12 | ITT population | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks) | Safety population: All randomized subjects who received at least 1 dose of study drug | participants | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 | Double-blind Placebo EOW | -11.6 | Standard Deviation 100.5 | percent change | |
| Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 | Double-blind Adalimumab EOW | -62.6 | Standard Deviation 59.53 | percent change | |
| Number of Sites of Enthesitis: Change From Baseline to Week 12 | Double-blind Placebo EOW | Baseline | 7.8 | Standard Deviation 7.49 | sites of enthesitis |
| Number of Sites of Enthesitis: Change From Baseline to Week 12 | Double-blind Adalimumab EOW | Baseline | 8.3 | Standard Deviation 8.89 | sites of enthesitis |
| Number of Sites of Enthesitis: Change From Baseline to Week 12 | Double-blind Placebo EOW | Week 12 | 5.1 | Standard Deviation 8.92 | sites of enthesitis |
| Number of Sites of Enthesitis: Change From Baseline to Week 12 | Double-blind Adalimumab EOW | Week 12 | 3.9 | Standard Deviation 6.60 | sites of enthesitis |
| Number of Sites of Enthesitis: Change From Baseline to Week 12 | Double-blind Placebo EOW | Change from Baseline to Week 12 | -2.7 | Standard Deviation 4.98 | sites of enthesitis |
| Number of Sites of Enthesitis: Change From Baseline to Week 12 | Double-blind Adalimumab EOW | Change from Baseline to Week 12 | -4.4 | Standard Deviation 6.20 | sites of enthesitis |
| Tender Joint Count (TJC72): Change From Baseline to Week 12 | Double-blind Placebo EOW | Baseline | 11.9 | Standard Deviation 9.34 | units on a scale |
| Tender Joint Count (TJC72): Change From Baseline to Week 12 | Double-blind Adalimumab EOW | Baseline | 13.4 | Standard Deviation 10.49 | units on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period | STARTED | Double-blind Placebo EOW | 15 | |
| Double-blind Period | STARTED | Double-blind Adalimumab EOW | 31 | |
| Double-blind Period | STARTED | Open-label Adalimumab EOW | 0 | |
| Double-blind Period | COMPLETED | Double-blind Placebo EOW | 15 | |
| Double-blind Period | COMPLETED | Double-blind Adalimumab EOW | 31 | |
| Double-blind Period | COMPLETED | Open-label Adalimumab EOW | 0 | |
| Double-blind Period | NOT COMPLETED | Double-blind Placebo EOW | 0 | |
| Double-blind Period | NOT COMPLETED | Double-blind Adalimumab EOW | 0 | |
| Double-blind Period | NOT COMPLETED | Open-label Adalimumab EOW | 0 | |
| Open-label Period | STARTED | Double-blind Placebo EOW | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events585
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 | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Double-blind Placebo EOW | 0 | 15 | |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Double-blind Adalimumab EOW | 0 | 31 | |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Any Adalimumab | 1 | 46 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Double-blind Placebo EOW | 0 | 15 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Double-blind Adalimumab EOW | 1 | 31 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Any Adalimumab | 1 | 46 | |
| other | EAR PAIN | Ear and labyrinth disorders | Double-blind Placebo EOW | 0 | 15 | |
| other | EAR PAIN | Ear and labyrinth disorders | Double-blind Adalimumab EOW | 1 | 31 | |
| other | EAR PAIN | Ear and labyrinth disorders | Any Adalimumab | 2 | 46 | |
| other | VERTIGO | Ear and labyrinth disorders | Double-blind Placebo EOW | 0 | 15 |
1 to 10 of 585Source ClinicalTrials.gov
See all 585 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Placebo EOW | ||
| Total, all-cause mortality | Double-blind Adalimumab EOW | ||
| Total, all-cause mortality | Any Adalimumab | ||
| Total, other adverse events | Double-blind Placebo EOW | 8 | 15 |
| Total, other adverse events | Double-blind Adalimumab EOW | 21 | 31 |
| Total, other adverse events | Any Adalimumab | 46 | 46 |
| Total, serious adverse events | Double-blind Placebo EOW | 0 | 15 |
| Total, serious adverse events | Double-blind Adalimumab EOW | 1 | 31 |
| Total, serious adverse events | Any Adalimumab | 10 | 46 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01166282
GET https://conductscience.org/api/trials/v1/NCT01166282/results?page=2