Arthritis, RheumatoidPhase 1NCT00550355
Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
A Phase 1 study testing PD 0360324 in people with Arthritis, Rheumatoid, run by Pfizer at 25 sites in 8 countries.
Trial summary
This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- PD 0360324
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 25 sitesin 8 countries
- Study dates
- Aug 2007to Jun 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA for at least 6 months based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- Must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16 weeks immediately prior to enrollment. The dose of methotrexate must be stable for at least 6 weeks prior to enrollment.
- Females of childbearing potential are required to simultaneously use 2 effective contraceptive methods, 1 of which must be a barrier (condoms, diaphragm or cervical cap) with spermicide. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures
- Contact your local site for more inclusion criteria.
Who cannot join
- Diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies); or a non-inflammatory arthritis or musculoskeletal condition (eg, osteoarthritis, fibromyalgia) that, in the investigator's opinion, may interfere with clinical assessments.
- Evidence of active or latent infection with Mycobacterium tuberculosis (TB).
- Use of etanercept, anakinra, or oral DMARDs with the exception of methotrexate, within the 4 weeks prior to enrollment. Use of biological DMARDs within the 8 (adalimumab or infliximab) or 12 (abatacept) or 56 (rituximab) weeks prior to enrollment. Use of oral corticosteroids, acetaminophen, NSAIDs, and opioids are permitted within the dose ranges defined in the protocol.
- Contact your local site for more inclusion criteria.
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
United States9 sites
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Frederick, Maryland, 21702
Pfizer Investigational Site
Lansing, Michigan, 48910-8595
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Port Orange, Florida, 32127
Poland6 sites
Pfizer Investigational Site
Bialystok, 15-461
Pfizer Investigational Site
Bialystok, 15-875
Pfizer Investigational Site
Krakow, 31-201
Pfizer Investigational Site
Krakow, 31-752
Pfizer Investigational Site
Warsaw, 02-637
Pfizer Investigational Site
Wroclaw, 51-124
Bulgaria3 sites
Pfizer Investigational Site
Pleven, 5800
Pfizer Investigational Site
Sofia, 1606
Pfizer Investigational Site
Sofia, 1612
Czechia2 sites
Pfizer Investigational Site
Brno, 656 91
Pfizer Investigational Site
Prague, 140 59
Mexico2 sites
Pfizer Investigational Site
México, D.F., 06700
Pfizer Investigational Site
Mexico City, Mexico City, 14050
About this study
Official title: A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate
This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- PD 0360324, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD 0360324Drug
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
PD 0360324Drug
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
PD 0360324Drug
3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
PlaceboDrug
3 doses of Placebo administered over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PD 0360324 |
| 2 | Experimental | Not described Receives: Drug: PD 0360324 |
| 3 | Experimental | Not described Receives: Drug: PD 0360324 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical safety laboratories
Measured: 16 weeks
Vital signs
Measured: 16 weeks
ECG
Measured: 16 weeks
Incidence and severity of adverse events
Measured: 16 weeks
Secondary outcomes (2)
Pharmacokinetic
Measured: 16 weeks
Pharmacodynamic
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2009
- Study completionJun 2009
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550355
- Sponsor's protocol ID
- A6261002
- Status last verified
- Jul 2009
- First submitted
- 25 Oct 2007
- Last updated
- 14 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate
- ClinicalTrials.gov ID
- NCT00550355
- Acronym / sponsor ID
- A6261002
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Oct 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.
This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PD 0360324 |
| 2 | Experimental | Drug: PD 0360324 |
| 3 | Experimental | Drug: PD 0360324 |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of RA for at least 6 months based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- Must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16 weeks immediately prior to enrollment. The dose of methotrexate must be stable for at least 6 weeks prior to enrollment.
- Females of childbearing potential are required to simultaneously use 2 effective contraceptive methods, 1 of which must be a barrier (condoms, diaphragm or cervical cap) with spermicide. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures
- Contact your local site for more inclusion criteria.
Key exclusion criteria (4 listed)
- Diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies); or a non-inflammatory arthritis or musculoskeletal condition (eg, osteoarthritis, fibromyalgia) that, in the investigator's opinion, may interfere with clinical assessments.
- Evidence of active or latent infection with Mycobacterium tuberculosis (TB).
- Use of etanercept, anakinra, or oral DMARDs with the exception of methotrexate, within the 4 weeks prior to enrollment. Use of biological DMARDs within the 8 (adalimumab or infliximab) or 12 (abatacept) or 56 (rituximab) weeks prior to enrollment. Use of oral corticosteroids, acetaminophen, NSAIDs, and opioids are permitted within the dose ranges defined in the protocol.
- Contact your local site for more inclusion criteria.
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 |
|---|---|---|
| PD 03603243 doses of PD 0360324 (Dose level 1) administered over 12 weeks | Drug | 1 |
| PD 03603243 doses of PD 0360324 (Dose level 2) administered over 12 weeks | Drug | 2 |
| PD 03603243 doses of PD 0360324 (Dose level 3) administered over 12 weeks | Drug | 3 |
| Placebo3 doses of Placebo administered over 12 weeks | Drug | 4 |
Primary outcome
Clinical safety laboratories
Time frame: 16 weeks
Vital signs
Time frame: 16 weeks
ECG
Time frame: 16 weeks
Incidence and severity of adverse events
Time frame: 16 weeks
2 secondary outcomes
Pharmacokinetic
Time frame: 16 weeks
Pharmacodynamic
Time frame: 16 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 14 Jul 2009.
- 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
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PD 0360324 in people with Arthritis, Rheumatoid, run by Pfizer at 25 sites in 8 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 4 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: finished, as of the sponsor's last update on 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Poland, Bulgaria, Czechia, Mexico and 3 more countries. 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. 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 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?
Clinical safety laboratories (time frame: 16 weeks). The study lists 4 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 14 Jul 2009; AzTrials last refreshed its copy on 3 Nov 2026.