Arthritis, RheumatoidPhase 2NCT00089921
SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate
A Phase 2 study testing SCIO-469 in people with Arthritis, Rheumatoid, run by Scios, Inc..
Trial summary
The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- SCIO-469
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Oct 2005
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs)
- Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study
Who cannot join
- Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
- Lab tests revealed elevated liver enzymes within the past 6 months
- Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy
- HIV positive
- Abnormal electrocardiogram
- Chronic or acute infection
About this study
Official title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine
The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).
Read the detailed description
This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- SCIO-469, Placebo
- Keywords
- Rheumatoid Arthritis, DMARDs, Methotrexate, p38 kinase
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCIO-469Drug
60 mg capsule three times daily for 12 weeks
SCIO-469Drug
30 mg capsule three times daily for 12 weeks
PlaceboDrug
2 capsules three times daily and one tablet daily
SCIO-469Drug
100 mg tablet once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | SCIO-469 30 mg capsule three times daily for 12 weeks Receives: Drug: SCIO-469 |
| 002 | Experimental | SCIO-469 60 mg capsule three times daily for 12 weeks Receives: Drug: SCIO-469 |
| 003 | Experimental | SCIO-469 100 mg tablet once daily for 12 weeks Receives: Drug: SCIO-469 |
| 004 | Placebo comparator | Placebo 2 capsules three times daily and one tablet daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)
Measured: Day 1 to approximately Day 85 of treatment
Secondary outcomes (5)
ACR50 responders at Week 12
Measured: 12 weeks
ACR20 and ACR50 responders at each evaluation visit other than Week 12
Measured: 24 weeks
All individual variables of the ACR response criteria at each evaluation visit
Measured: 24 weeks
Disease Activity Score (DAS)28 at each evaluation visit.
Measured: 24 Weeks
The number of participants experiencing adverse events (AEs) as a measure of safety
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2004 (estimated)
- Study startJul 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 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
- NCT00089921
- Sponsor's protocol ID
- CR005167
- Other IDs
- SCIO-469ARA2003, B007
- Status last verified
- Oct 2010
- First submitted
- 17 Aug 2004
- Last updated
- 18 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine
- ClinicalTrials.gov ID
- NCT00089921
- Acronym / sponsor ID
- CR005167
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, DMARDs, Methotrexate, p38 kinase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 20 Aug 2004 (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 primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).
Detailed description
This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: SCIO-469SCIO-469 30 mg capsule three times daily for 12 weeks |
| 002 | Experimental | Drug: SCIO-469SCIO-469 60 mg capsule three times daily for 12 weeks |
| 003 | Experimental | Drug: SCIO-469SCIO-469 100 mg tablet once daily for 12 weeks |
| 004 | Placebo comparator | Drug: PlaceboPlacebo 2 capsules three times daily and one tablet daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs)
- Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study
Key exclusion criteria (6 listed)
- Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
- Lab tests revealed elevated liver enzymes within the past 6 months
- Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy
- HIV positive
- Abnormal electrocardiogram
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 |
|---|---|---|
| SCIO-46960 mg capsule three times daily for 12 weeks | Drug | 002 |
| SCIO-46930 mg capsule three times daily for 12 weeks | Drug | 001 |
| Placebo2 capsules three times daily and one tablet daily | Drug | 004 |
| SCIO-469100 mg tablet once daily for 12 weeks | Drug | 003 |
Primary outcome
ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)
Time frame: Day 1 to approximately Day 85 of treatment
5 secondary outcomes
ACR50 responders at Week 12
Time frame: 12 weeks
ACR20 and ACR50 responders at each evaluation visit other than Week 12
Time frame: 24 weeks
All individual variables of the ACR response criteria at each evaluation visit
Time frame: 24 weeks
Disease Activity Score (DAS)28 at each evaluation visit.
Time frame: 24 Weeks
The number of participants experiencing adverse events (AEs) as a measure of safety
Time frame: 24 weeks
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 18 Oct 2010.
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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 2 study testing SCIO-469 in people with Arthritis, Rheumatoid, 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 2 inclusion and 6 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 18 Oct 2010. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR) (time frame: Day 1 to approximately Day 85 of treatment). 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 18 Oct 2010.