Trial · NCT00095173
BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
NCT00095173, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2017-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis. Trials, record NCT00095173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095173
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
- NCT number
- NCT00095173
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Juvenile Rheumatoid Arthritis
- Interventions
- Abatacept, Placebo, Abatacept
- First posted
- 2004-11-02
- Last updated
- 2017-01-18
- Results first posted
- 2017-01-18
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) | Period B (Day 113 to Day 282) | Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed. All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR) |
| Secondary | Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B) | Period B (Day 113 to Day 282) | All of the following criteria must be met to be defined as a flare: * \> 30% worsening in at least 3 of the 6 JRA/JIA core response variables * \> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables * ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare * worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR) |
| Secondary | Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A) | Period A (Day 1 to Day 113) | AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1). |
| Secondary | Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B) | Period B (Day 113 to Day 282) | AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1). |
| Secondary | Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C) | Period C (Day 282 to end of study) | AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1). |
| Secondary | Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B) | Period B (Day 113 to Day 282) | Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being. |
| Secondary | Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C) | Period C (Day 282 to end of study) | Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being. |
| Secondary | Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies | Period A (Day 1 to Day 113) | The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest. |
| Secondary | Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies | Period B (Day 113 to Day 282) | The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest. |
| Secondary | Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies | Period C (Day 282 up to 56 days after the last dose of study medication) | The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) | Period B (Day 113 to Day 282) | All treated participants | months | MEDIAN |
| SECONDARY | Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B) | Period B (Day 113 to Day 282) | All treated participants | participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A) | Period A (Day 1 to Day 113) | All treated participants in Periods A | participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B) | Period B (Day 113 to Day 282) | All treated participants in Periods B | participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C) | Period C (Day 282 to end of study) | All treated participants in Period C | participants | NUMBER |
| SECONDARY | Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B) | Period B (Day 113 to Day 282) | All treated participants in Period B | percentage change from baseline | MEDIAN |
| SECONDARY | Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C) | Period C (Day 282 to end of study) | All treated participants in Period C | percentage change from baseline | MEDIAN |
| SECONDARY | Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies | Period A (Day 1 to Day 113) | All treated participants in Period A | participants | NUMBER |
| SECONDARY | Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies | Period B (Day 113 to Day 282) | All treated participants in Period B | participants | NUMBER |
| SECONDARY | Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies | Period C (Day 282 up to 56 days after the last dose of study medication) | All treated participants in Period C | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group235
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) | Abatacept (Period B) | NA | Full Range NA to NA | months | |
| Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) | Placebo (Period B) | 6 | Full Range 0.73 to 6.87 | months | |
| Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B) | Abatacept (Period B) | 12 | participants | ||
| Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B) | Placebo (Period B) | 33 | participants | ||
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A) | Abatacept (All Participants in Period A) | SAE | 6 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A) | Abatacept (All Participants in Period A) | Treatment-Related AE | 0 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A) | Abatacept (All Participants in Period A) | All Deaths | 0 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A) | Abatacept (All Participants in Period A) | Treatment-Related Deaths | 0 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A) | Abatacept (All Participants in Period A) | Discontinuation of Study Drug due to AEs | 1 | participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B) | Abatacept (Period B) | SAE | 0 | participants |
1 to 10 of 235Source ClinicalTrials.gov
See all 235 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Lead-In Phase (Period A) | STARTED | Abatacept (All Participants in Period A) | 190 | |
| Open-Label Lead-In Phase (Period A) | STARTED | Abatacept (Period B) | 0 | |
| Open-Label Lead-In Phase (Period A) | STARTED | Placebo (Period B) | 0 | |
| Open-Label Lead-In Phase (Period A) | STARTED | Abatacept (Period A Non-Responders in Period C) | 0 | |
| Open-Label Lead-In Phase (Period A) | STARTED | Abatacept (Period C) | 0 | |
| Open-Label Lead-In Phase (Period A) | STARTED | Placebo (Period B) to Abatacept (Period C) | 0 | |
| Open-Label Lead-In Phase (Period A) | COMPLETED | Abatacept (All Participants in Period A) | 170 | |
| Open-Label Lead-In Phase (Period A) | COMPLETED | Abatacept (Period B) | 0 | |
| Open-Label Lead-In Phase (Period A) | COMPLETED | Placebo (Period B) | 0 | |
| Open-Label Lead-In Phase (Period A) | COMPLETED | Abatacept (Period A Non-Responders in Period C) | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events480
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 | Anaemia | Blood and lymphatic system disorders | Abatacept (Only Period A) | 0 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Abatacept (Period A/Period C) | 2 | 36 | |
| other | Anaemia | Blood and lymphatic system disorders | Abatacept (Period A/Period B) | 3 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | Abatacept (Period A)/Placebo (Period B) | 5 | 62 | |
| other | Fatigue | General disorders | Abatacept (Only Period A) | 2 | 32 | |
| other | Fatigue | General disorders | Abatacept (Period A/Period C) | 2 | 36 | |
| other | Fatigue | General disorders | Abatacept (Period A/Period B) | 0 | 60 | |
| other | Fatigue | General disorders | Abatacept (Period A)/Placebo (Period B) | 1 | 62 | |
| other | Hypertension | Vascular disorders | Abatacept (Only Period A) | 0 | 32 | |
| other | Hypertension | Vascular disorders | Abatacept (Period A/Period C) | 2 | 36 |
1 to 10 of 480Source ClinicalTrials.gov
See all 480 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept (Only Period A) | ||
| Total, all-cause mortality | Abatacept (Period A/Period C) | ||
| Total, all-cause mortality | Abatacept (Period A/Period B) | ||
| Total, all-cause mortality | Abatacept (Period A)/Placebo (Period B) | ||
| Total, other adverse events | Abatacept (Only Period A) | 22 | 32 |
| Total, other adverse events | Abatacept (Period A/Period C) | 32 | 36 |
| Total, other adverse events | Abatacept (Period A/Period B) | 57 | 60 |
| Total, other adverse events | Abatacept (Period A)/Placebo (Period B) | 54 | 62 |
| Total, serious adverse events | Abatacept (Only Period A) | 4 | 32 |
| Total, serious adverse events | Abatacept (Period A/Period C) | 10 | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Abatacept (Period B) vs Placebo (Period B): Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B) |
Source 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.
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GET https://conductscience.org/api/trials/v1/NCT00095173/results?page=2