Trial Outcomes & Findings for Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis (NCT NCT00688545)

Last Updated: 2021-02-02

Results Overview

Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry.

Recruitment status

TERMINATED

Target enrollment

275 participants

Primary outcome timeframe

Baseline up to 2 years

Results posted on

2021-02-02

Participant Flow

A total of 275 people consented to participate in this study. One person should not have been enrolled and instead should have been a screen failure. This person did not receive any study drug.

Participant milestones

Participant milestones
Measure	Celecoxib Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.	nsNSAIDs Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
Overall Study STARTED	55	219
Overall Study Switched Treatment at Least Once	6	13
Overall Study COMPLETED	50	204
Overall Study NOT COMPLETED	5	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Celecoxib Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.	nsNSAIDs Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
Overall Study Lost to Follow-up	1	4
Overall Study Insurance/cost of drug	0	1
Overall Study Withdrawal by Subject	2	3
Overall Study Unspecified, unrelated to AE/Toxicity	2	7

Baseline Characteristics

Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celecoxib n=55 Participants Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.	nsNSAIDs n=219 Participants Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.	Total n=274 Participants Total of all reporting groups
Age, Customized 2-5 years	8 Participants n=5 Participants	77 Participants n=7 Participants	85 Participants n=5 Participants
Age, Customized 6-9 years	17 Participants n=5 Participants	52 Participants n=7 Participants	69 Participants n=5 Participants
Age, Customized 10-12 years	15 Participants n=5 Participants	44 Participants n=7 Participants	59 Participants n=5 Participants
Age, Customized 13-15 years	7 Participants n=5 Participants	35 Participants n=7 Participants	42 Participants n=5 Participants
Age, Customized 16-18 years	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	165 Participants n=7 Participants	212 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	54 Participants n=7 Participants	62 Participants n=5 Participants
Juvenile Idiopathic Arthritis (JIA) Systemic	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Juvenile Idiopathic Arthritis (JIA) Persistent Oligoarticular	27 Participants n=5 Participants	119 Participants n=7 Participants	146 Participants n=5 Participants
Juvenile Idiopathic Arthritis (JIA) Extended Oligoarticular	2 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants
Juvenile Idiopathic Arthritis (JIA) Poly RF-	23 Participants n=5 Participants	70 Participants n=7 Participants	93 Participants n=5 Participants
Juvenile Idiopathic Arthritis (JIA) Poly RF+	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants
Juvenile Idiopathic Arthritis (JIA) Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Heartburn	9 Participants n=5 Participants	21 Participants n=7 Participants	30 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Upper stomach pain	8 Participants n=5 Participants	18 Participants n=7 Participants	26 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Lower stomach pain	16 Participants n=5 Participants	34 Participants n=7 Participants	50 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Nausea	14 Participants n=5 Participants	32 Participants n=7 Participants	46 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Diarrhea	5 Participants n=5 Participants	18 Participants n=7 Participants	23 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Constipation	5 Participants n=5 Participants	16 Participants n=7 Participants	21 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Vomiting	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Poor appetite	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems No problems	23 Participants n=5 Participants	132 Participants n=7 Participants	155 Participants n=5 Participants
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems Missing	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
JIA medications Gastrointestinal (GI) protective agents	18 Participants n=5 Participants	48 Participants n=7 Participants	66 Participants n=5 Participants
JIA medications Other GI	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
JIA medications Disease-modifying antirheumatic drugs (DMARDs)	21 Participants n=5 Participants	83 Participants n=7 Participants	104 Participants n=5 Participants
JIA medications Biologics	8 Participants n=5 Participants	28 Participants n=7 Participants	36 Participants n=5 Participants
JIA medications Antihypertensives	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
JIA medications NSAIDs (Celecoxib)	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
JIA medications NSAIDs (Diclofenac)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
JIA medications NSAIDs (Ibuprofen)	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
JIA medications NSAIDs (Meloxicam)	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
JIA medications NSAIDs (Naproxen)	0 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants
JIA medications NSAIDs (Other)	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
JIA medications Corticosteroids (Oral, IV, Intra-Articular)	5 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants
JIA medications Corticosteroids (Other)	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
JIA medications Analgesics (Acetaminophen, Opioids, Other)	9 Participants n=5 Participants	18 Participants n=7 Participants	27 Participants n=5 Participants
Number of participants with abnormal physical exam results	17 Participants n=5 Participants	63 Participants n=7 Participants	80 Participants n=5 Participants
Physician Global Assessment (PGA) of Disease Activity	2.6 Units on a scale STANDARD_DEVIATION 2.36 • n=5 Participants	2.9 Units on a scale STANDARD_DEVIATION 2.19 • n=7 Participants	2.8 Units on a scale STANDARD_DEVIATION 2.22 • n=5 Participants
Participant or caregiver's assessment of participant's overall well-being	3.2 Units on a scale STANDARD_DEVIATION 2.58 • n=5 Participants	2.8 Units on a scale STANDARD_DEVIATION 2.50 • n=7 Participants	2.9 Units on a scale STANDARD_DEVIATION 2.52 • n=5 Participants
Child Health Questionnaire (CHAQ) - global evaluation	29.11 Units on a scale STANDARD_DEVIATION 29.34 • n=5 Participants	20.15 Units on a scale STANDARD_DEVIATION 21.58 • n=7 Participants	21.96 Units on a scale STANDARD_DEVIATION 23.56 • n=5 Participants
CHAQ - pain	0.92 Units on a scale STANDARD_DEVIATION 0.85 • n=5 Participants	0.71 Units on a scale STANDARD_DEVIATION 0.72 • n=7 Participants	0.75 Units on a scale STANDARD_DEVIATION 0.75 • n=5 Participants
CHAQ - functioning	0.65 Units on a scale STANDARD_DEVIATION 0.68 • n=5 Participants	0.48 Units on a scale STANDARD_DEVIATION 0.54 • n=7 Participants	0.52 Units on a scale STANDARD_DEVIATION 0.57 • n=5 Participants
Number of joints with active arthritis	3.4 Joints STANDARD_DEVIATION 5.39 • n=5 Participants	2.9 Joints STANDARD_DEVIATION 4.14 • n=7 Participants	3.0 Joints STANDARD_DEVIATION 4.42 • n=5 Participants
GISSK - severity of stomach problems	21.9 Units on a scale STANDARD_DEVIATION 25.75 • n=5 Participants	12.0 Units on a scale STANDARD_DEVIATION 19.84 • n=7 Participants	14.0 Units on a scale STANDARD_DEVIATION 21.47 • n=5 Participants
Body weight	33.60 kilogram (kg) n=5 Participants	30.20 kilogram (kg) n=7 Participants	30.90 kilogram (kg) n=5 Participants
Height	141.30 centimeters (cm) n=5 Participants	130.10 centimeters (cm) n=7 Participants	132.00 centimeters (cm) n=5 Participants
Body Mass Index (BMI)	17.70 kilograms per meter squared (kg/m^2) n=5 Participants	17.31 kilograms per meter squared (kg/m^2) n=7 Participants	17.55 kilograms per meter squared (kg/m^2) n=5 Participants
Weight and Height percentiles overall Weight	47.22 Percentile STANDARD_DEVIATION 29.95 • n=5 Participants	56.68 Percentile STANDARD_DEVIATION 30.96 • n=7 Participants	54.76 Percentile STANDARD_DEVIATION 30.94 • n=5 Participants
Weight and Height percentiles overall Height	42.77 Percentile STANDARD_DEVIATION 29.59 • n=5 Participants	50.70 Percentile STANDARD_DEVIATION 30.76 • n=7 Participants	49.08 Percentile STANDARD_DEVIATION 30.63 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 2 years

Population: Safety Analysis Set: participants who were prescribed at least one dose of any NSAID. Participants who switched treatment were counted for the NSAID utilized at the time of the event, regardless of the initial NSAID treatment at enrollment.

Outcome measures

Outcome measures
Measure	Celecoxib n=68 Participants Participants who received celecoxib at any time during the study. Treatment assignment as per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.	nsNSAIDs n=225 Participants Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	36 Participants	117 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	9 Participants

PRIMARY outcome

Timeframe: Year 2 or early termination

Population: Safety Analysis Set subset of participants who received JIA concomitant medications

JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication.

Outcome measures

Outcome measures
Measure	Celecoxib n=39 Participants Participants who received celecoxib at any time during the study. Treatment assignment as per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.	nsNSAIDs n=148 Participants Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
JIA Concomitant Medications GI protective agents	20 Participants	54 Participants
JIA Concomitant Medications Other GI	5 Participants	8 Participants
JIA Concomitant Medications DMARDs	24 Participants	102 Participants
JIA Concomitant Medications Biologics	13 Participants	60 Participants
JIA Concomitant Medications Antihypertensives	1 Participants	4 Participants
JIA Concomitant Medications NSAIDs (Celecoxib)	7 Participants	2 Participants
JIA Concomitant Medications NSAIDs (Diclofenac)	0 Participants	0 Participants
JIA Concomitant Medications NSAIDs (Ibuprofen)	1 Participants	9 Participants
JIA Concomitant Medications NSAIDs (Meloxicam)	1 Participants	8 Participants
JIA Concomitant Medications NSAIDs (Naproxen)	0 Participants	7 Participants
JIA Concomitant Medications NSAIDs (Other)	0 Participants	3 Participants
JIA Concomitant Medications Corticosteroids (oral, IV, intra-articular)	4 Participants	15 Participants
JIA Concomitant Medications Corticosteroids (Other)	2 Participants	6 Participants
JIA Concomitant Medications Analgesics (Acetaminophen, Opioids, Other)	11 Participants	19 Participants

Adverse Events

Celecoxib

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

nsNSAIDs

Serious events: 9 serious events

Other events: 114 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Celecoxib n=68 participants at risk Participants who were prescribed celecoxib at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.	nsNSAIDs n=225 participants at risk Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
General disorders Condition Aggravated	1.5% 1/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.00% 0/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
General disorders Pyrexia	1.5% 1/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.00% 0/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Infections and infestations Cellulitis	1.5% 1/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Infections and infestations Appendicitis	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Infections and infestations Arthritis Bacterial	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Infections and infestations Meningitis	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Musculoskeletal and connective tissue disorders Juvenile Arthritis	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous Histiocytoma	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Nervous system disorders Migraine	1.5% 1/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.00% 0/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
Pregnancy, puerperium and perinatal conditions Unintended Pregnancy	0.00% 0/68 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.	0.44% 1/225 Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER