Rheumatoid ArthritisPhase 1NCT00920608
A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients
A Phase 1 study testing AZD9056 and Methotrexate in people with Rheumatoid Arthritis, run by AstraZeneca.
Trial summary
The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- AZD9056 and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Sep 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with rheumatoid arthritis
- Currently on Methotrexate treatment
- Provision of informed consent
Who cannot join
- History of malignancy (except for treated squamous and basal cell carcinoma of the skin more than 5 years prior to entry)
- Patients who were taking prescription of medications listed below:
- Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin
- Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1
About this study
Official title: A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis
The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.
- Conditions
- Rheumatoid Arthritis
- Being tested
- AZD9056, Methotrexate
- Keywords
- AZD9056, Pharmacokinetics, interaction, Methotrexate, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9056Drug
Tablets for oral use. 400 mg once daily for 7 days
MethotrexateDrug
Also called Various brands used
Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AZD9056 400 mg and Methotrexate Receives: Drug: AZD9056; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of AZD9056 and Methotrexate
Measured: Pharmacokinetic samples for Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
Secondary outcomes (2)
Pharmacokinetics of AZD9056 and 7-OH Methotrexate
Measured: Pharmacokinetics samples for 7-OH Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.)
Measured: During the whole study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startMay 2009
- Study completionSep 2009 (estimated)
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.
- More trials run by AstraZenecaThe 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920608
- Sponsor's protocol ID
- D1520C00027
- Status last verified
- Dec 2010
- First submitted
- 12 Jun 2009
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00920608
- Acronym / sponsor ID
- D1520C00027
- Conditions
- Rheumatoid Arthritis
- Keywords
- AZD9056, Pharmacokinetics, interaction, Methotrexate, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Sep 2009 (estimated)
- First posted
- 15 Jun 2009 (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 main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD9056, Drug: MethotrexateAZD9056 400 mg and Methotrexate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with rheumatoid arthritis
- Currently on Methotrexate treatment
- Provision of informed consent
Key exclusion criteria (4 listed)
- History of malignancy (except for treated squamous and basal cell carcinoma of the skin more than 5 years prior to entry)
- Patients who were taking prescription of medications listed below:
- Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin
- Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1
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 |
|---|---|---|
| AZD9056Tablets for oral use. 400 mg once daily for 7 days | Drug | A |
| MethotrexateAlso: Various brands usedTablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3. | Drug | A |
Primary outcome
Pharmacokinetics of AZD9056 and Methotrexate
Time frame: Pharmacokinetic samples for Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
2 secondary outcomes
Pharmacokinetics of AZD9056 and 7-OH Methotrexate
Time frame: Pharmacokinetics samples for 7-OH Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.)
Time frame: During the whole study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD9056 and Methotrexate in people with Rheumatoid Arthritis, run by AstraZeneca.
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 3 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: withdrawn, as of the sponsor's last update on 3 Dec 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetics of AZD9056 and Methotrexate (time frame: Pharmacokinetic samples for Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state). 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 3 Dec 2010.