Arthritis, Juvenile RheumatoidPhase 4NCT00637780
Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
A Phase 4 study testing Sulfasalazine in people with Arthritis, Juvenile Rheumatoid, run by Pfizer at 2 sites in 2 countries.
Trial summary
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study will fulfill the post approval commitment to the FDA. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Arthritis, Juvenile Rheumatoid
- What is being tested?
- Sulfasalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2010to Jan 2014
- Phase
- Phase 4
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or enthesitis-related JIA as determined by ILAR criteria. Patients who have been continuously treated with generic sulfasalazine delayed release formulation and have tolerated the product for at least 3 months prior to study enrolment and who are switched to Azulfidine-EN at least 8 days prior to Day 0 are eligible.
- Patients must be at least 6 years of age and has not reached his/her 18th birthday prior to the Baseline Visit (Day 0).
- Onset of JIA must have occurred prior to the patient's 16th birthday.
- Patients must weigh at least 20 kg.
- Patients must be on sulfasalazine 500 mg delayed release tablets and the total daily dose must be within the specified range of 30-60 mg/kg/day with a maximum daily dose of 3 g/day
Who cannot join
- Patient currently with systemic features of systemic JIA.
- Hypersensitivity to sulfasalazine , its metabolites, sulfonamides or salicylates.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Inability to swallow whole (uncrushed) sulfasalazine 500 mg delayed release tablets as required by protocol
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study will fulfill the post approval commitment to the FDA.
- Conditions
- Arthritis, Juvenile Rheumatoid
- Being tested
- Sulfasalazine
- Keywords
- Sulfasalazine delayed release tablets, azulfidine entabs, Pharmacokinetics, Juvenile Idiopathic Arthritis (JIA)
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfasalazineDrug
Also called AZULFIDINE EN-tabs Tablets
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days Receives: Drug: Sulfasalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfasalazine Time for Cmax (Tmax) at Steady State
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine Steady State Cmax and Cmin
Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine Tmax at Steady State
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine AUCtau at Steady State
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
5-aminosalicylic Acid (5-ASA) Tmax at Steady State
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
5-aminosalicylic Acid (5-ASA) AUCtau at Steady State
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Measured: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Secondary outcomes (3)
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening through to and including 28 calendar days after the last administration of the investigational product
Number of Participants With Laboratory Test Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes,clinical chemistry, and urinalysis (dipstick and microscopy).
Measured: Screening, Day 0, and Day 7
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Vital sign values which met categorical summarization criteria included: supine/sitting pulse rate less than (<) 40 or more than (>) 120 beats per minute (bpm); erect pulse rate <40 or >140 bpm; changes from baseline in same posture of systolic blood pressure (SBP) more than or equal to (>=) 30 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >=20 mm Hg; SBP <90 mm Hg; and DBP <50 mm Hg.
Measured: Screening, Day 0, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startJun 2010
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Study terminated on 13 April 2016 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study
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 Arthritis, Juvenile RheumatoidStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637780
- Sponsor's protocol ID
- A0031005
- Status last verified
- Jan 2017
- First submitted
- 11 Mar 2008
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT00637780
- Acronym / sponsor ID
- A0031005
- Conditions
- Arthritis, Juvenile Rheumatoid
- Keywords
- Sulfasalazine delayed release tablets, azulfidine entabs, Pharmacokinetics, Juvenile Idiopathic Arthritis (JIA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated on 13 April 2016 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study will fulfill the post approval commitment to the FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SulfasalazineSulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or enthesitis-related JIA as determined by ILAR criteria. Patients who have been continuously treated with generic sulfasalazine delayed release formulation and have tolerated the product for at least 3 months prior to study enrolment and who are switched to Azulfidine-EN at least 8 days prior to Day 0 are eligible.
- Patients must be at least 6 years of age and has not reached his/her 18th birthday prior to the Baseline Visit (Day 0).
- Onset of JIA must have occurred prior to the patient's 16th birthday.
- Patients must weigh at least 20 kg.
- Patients must be on sulfasalazine 500 mg delayed release tablets and the total daily dose must be within the specified range of 30-60 mg/kg/day with a maximum daily dose of 3 g/day
Key exclusion criteria (4 listed)
- Patient currently with systemic features of systemic JIA.
- Hypersensitivity to sulfasalazine , its metabolites, sulfonamides or salicylates.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Inability to swallow whole (uncrushed) sulfasalazine 500 mg delayed release tablets as required by protocol
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 |
|---|---|---|
| SulfasalazineAlso: AZULFIDINE EN-tabs TabletsSulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7 | Drug | 1 |
Primary outcome
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfasalazine Time for Cmax (Tmax) at Steady State
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine Steady State Cmax and Cmin
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.
Sulfapyridine Tmax at Steady State
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Sulfapyridine AUCtau at Steady State
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) Tmax at Steady State
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) AUCtau at Steady State
Time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
3 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
Time frame: Screening through to and including 28 calendar days after the last administration of the investigational product
Number of Participants With Laboratory Test Abnormalities
Time frame: Screening, Day 0, and Day 7
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Time frame: Screening, Day 0, and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfasalazine in people with Arthritis, Juvenile Rheumatoid, run by Pfizer at 2 sites in 2 countries.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Feb 2017). 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?
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) (time frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.