Rheumatoid ArthritisPhase 1NCT00508768
A Study of Oral SCIO-469 Pharmacokinetics (Study of a Drug in the Body to Watch How the Drug is Absorbed, Distributed, Metabolized and Eliminated Over a Period of Time) in the Body of Female Patients With Active Rheumatoid Arthritis
A Phase 1 study testing Oral SCIO-469 capsule in people with Rheumatoid Arthritis, run by Scios, Inc..
Trial summary
The purpose of this study is to assess the pharmacokinetics of two oral dosing regimens of SCIO-469, with and without methotrexate, in patients with active rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Oral SCIO-469 capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active rheumatoid arthritis
- Patients on methotrexate are required to have taken a stable methotrexate dose of 15 to 25 mg/week (or lower maximum-tolerated dose level) for at least 1 month before study entry
- Patients with no methotrexate are required to have taken no methotrexate for at least 1 month before study entry
- Non steroidal anti inflammatory drugs (NSAIDs) and low-dose prednisone are allowed if doses had been stable for at least 1 month before study entry
- Patients of childbearing potential must have agreed to practice two forms of birth control for the duration of the trial.
Who cannot join
- Have taken infliximab or experimental biological antagonists (e.g., TNF antagonists) within the 3-month period before study entry
- Have used leflunomide within the 3 month period before study entry
- Have taken etanercept, anakinra, and disease-modifying anti-rheumatic drugs (DMARDs) other than leflunomide (and methotrexate) within the 4-week period before study entry
- Received intra-articular, intramuscular, or intravenous (IV) doses of corticosteroids or received oral doses of corticosteroids exceeding 10 mg/day within the 4-week period before study entry
- Elevated levels (greater than 1.2 times the upper limit of normal) of aspartate transaminase or alanine transaminase within the 6-month period before study entry.
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Pharmacokinetic Study of Oral SCIO-469 (90 mg qd and 30 mg Tid) in Female Subjects With Active Rheumatoid Arthritis
The purpose of this study is to assess the pharmacokinetics of two oral dosing regimens of SCIO-469, with and without methotrexate, in patients with active rheumatoid arthritis.
Read the detailed description
SCIO-469 is being developed for the treatment of active rheumatoid arthritis, a disease that occurs mostly in women; therefore, female patients with active rheumatoid arthritis are selected as the study population. This study is the first detailed pharmacokinetic evaluation (study of a drug in the body to watch how the drug is absorbed, distributed, metabolized and eliminated over a period of time) of SCIO-469 in a new capsule formulation. Methotrexate is frequently prescribed as treatment for patients with rheumatoid arthritis; thus, SCIO-469 could potentially be used along with methotrexate. It is not known how methotrexate affects the pharmacokinetics of SCIO-469; therefore, the study is designed to include patients who are taking stable doses of methotrexate and patients who are not taking methotrexate. This is a Phase II, randomized (study medication assigned by chance), double-blind (neither the patient or the physician knows which study treatment the patient is receiving), parallel-group study designed to assess the pharmacokinetics, safety, and tolerability of SCIO-469 in female patients with active rheumatoid arthritis. Sixteen patients will be enrolled in the study, with eight receiving stable doses of methotrexate and eight not receiving methotrexate. No other disease-modifying anti-rheumatic drugs (DMARDs) are allowed. Pharmacokinetics will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate). Safety assessments for this study include clinical adverse events, concomitant medications, and clinical assessments (medical history, physical examination, vital and orthostatic vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations [serum chemistry, urinalysis, hematology, liver function and other tests, and pregnancy test]). Patients receiving stable doses of methotrexate (taken once a week, either orally or by injection) and those not receiving methotrexate will be randomized into one of two oral capsule SCIO-469 dosing regimens: 30 mg three times a day and 90 mg once a day. Patients will take study drug for 11 of 12 days, with no study drug taken on Day 2. On Day 19, seven days after the end of treatment, patients will undergo a follow-up assessment of safety variables.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Oral SCIO-469 capsule
- Keywords
- Rheumatoid Arthritis, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral SCIO-469 capsuleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate).
Secondary outcomes (1)
Safety variables will be assessed on Day 19, seven days after the end of treatment, and will include adverse events, concomitant medications, and clinical assessments (medical history, physical exam, vital signs, 12-lead ECG, and clinical labs).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scios, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scios, Inc. Clinical Trial, Study director, Scios, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508768
- Sponsor's protocol ID
- CR005155
- Status last verified
- Apr 2010
- First submitted
- 27 Jul 2007
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Pharmacokinetic Study of Oral SCIO-469 (90 mg qd and 30 mg Tid) in Female Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00508768
- Acronym / sponsor ID
- CR005155
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Methotrexate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study completion
- Dec 2002 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the pharmacokinetics of two oral dosing regimens of SCIO-469, with and without methotrexate, in patients with active rheumatoid arthritis.
Detailed description
SCIO-469 is being developed for the treatment of active rheumatoid arthritis, a disease that occurs mostly in women; therefore, female patients with active rheumatoid arthritis are selected as the study population. This study is the first detailed pharmacokinetic evaluation (study of a drug in the body to watch how the drug is absorbed, distributed, metabolized and eliminated over a period of time) of SCIO-469 in a new capsule formulation. Methotrexate is frequently prescribed as treatment for patients with rheumatoid arthritis; thus, SCIO-469 could potentially be used along with methotrexate. It is not known how methotrexate affects the pharmacokinetics of SCIO-469; therefore, the study is designed to include patients who are taking stable doses of methotrexate and patients who are not taking methotrexate. This is a Phase II, randomized (study medication assigned by chance), double-blind (neither the patient or the physician knows which study treatment the patient is receiving), parallel-group study designed to assess the pharmacokinetics, safety, and tolerability of SCIO-469 in female patients with active rheumatoid arthritis. Sixteen patients will be enrolled in the study, with eight receiving stable doses of methotrexate and eight not receiving methotrexate. No other disease-modifying anti-rheumatic drugs (DMARDs) are allowed. Pharmacokinetics will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate). Safety assessments for this study include clinical adverse events, concomitant medications, and clinical assessments (medical history, physical examination, vital and orthostatic vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations [serum chemistry, urinalysis, hematology, liver function and other tests, and pregnancy test]). Patients receiving stable doses of methotrexate (taken once a week, either orally or by injection) and those not receiving methotrexate will be randomized into one of two oral capsule SCIO-469 dosing regimens: 30 mg three times a day and 90 mg once a day. Patients will take study drug for 11 of 12 days, with no study drug taken on Day 2. On Day 19, seven days after the end of treatment, patients will undergo a follow-up assessment of safety variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with active rheumatoid arthritis
- Patients on methotrexate are required to have taken a stable methotrexate dose of 15 to 25 mg/week (or lower maximum-tolerated dose level) for at least 1 month before study entry
- Patients with no methotrexate are required to have taken no methotrexate for at least 1 month before study entry
- Non steroidal anti inflammatory drugs (NSAIDs) and low-dose prednisone are allowed if doses had been stable for at least 1 month before study entry
- Patients of childbearing potential must have agreed to practice two forms of birth control for the duration of the trial.
Key exclusion criteria (5 listed)
- Have taken infliximab or experimental biological antagonists (e.g., TNF antagonists) within the 3-month period before study entry
- Have used leflunomide within the 3 month period before study entry
- Have taken etanercept, anakinra, and disease-modifying anti-rheumatic drugs (DMARDs) other than leflunomide (and methotrexate) within the 4-week period before study entry
- Received intra-articular, intramuscular, or intravenous (IV) doses of corticosteroids or received oral doses of corticosteroids exceeding 10 mg/day within the 4-week period before study entry
- Elevated levels (greater than 1.2 times the upper limit of normal) of aspartate transaminase or alanine transaminase within the 6-month period before study entry.
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 |
|---|---|---|
| Oral SCIO-469 capsule | Drug | – |
Primary outcome
Pharmacokinetic parameters will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate).
1 secondary outcome
Safety variables will be assessed on Day 19, seven days after the end of treatment, and will include adverse events, concomitant medications, and clinical assessments (medical history, physical exam, vital signs, 12-lead ECG, and clinical labs).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- A Pharmacokinetic Study of Oral SCIO-469 in Female Subjects with Active Rheumatoid ArthritisLink 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.
Scios, Inc. Clinical Trial study director
Scios, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral SCIO-469 capsule in people with Rheumatoid Arthritis, run by Scios, Inc..
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 5 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: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic parameters will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate).. 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 19 May 2011.