Ankylosing SpondylitisPhase 2NCT00811499
A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
A Phase 2 study testing ARRY-371797, p38 inhibitor; oral in people with Ankylosing Spondylitis, run by Pfizer at 12 sites in 2 countries.
Trial summary
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- ARRY-371797, p38 inhibitor; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 16 Dec 2008to 29 Sep 2009
- 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
- Diagnosis of ankylosing spondylitis according to the Modified New York Criteria (1984).
- Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance.
- If previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug.
- Patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug).
- Additional criteria exist.
Who cannot join
- Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments.
- Previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug.
- Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study.
- Trauma or other major surgeries within 8 weeks prior to first dose of study drug.
- Specific abnormal laboratory values or electrocardiogram abnormalities.
- Known positive serology for human immunodeficiency virus (HIV), hepatitis C, and/or hepatitis B.
- Additional criteria exist.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States7 sites
Low Country Rheumatology
Charleston, South Carolina, 29406
Northwestern University
Chicago, Illinois, 60611
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Westroads Medical Group
Omaha, Nebraska, 68114
Oregon Health & Science University
Portland, Oregon, 97239
Arthritis Northwest
Spokane, Washington, 99204
Canada5 sites
Rheumatology Research Associates Group
Edmonton, Alberta, T5M 0H4
Credit Valley Rheumatology
Mississauga, Ontario, L5M 2V8
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
Center de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z IY2
University of Manitoba
Winnipeg, Manitoba, R3A 1M4
About this study
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients from the US, Canada, Poland and Hungary will be enrolled in this study.
- Conditions
- Ankylosing Spondylitis
- Being tested
- ARRY-371797, p38 inhibitor; oral, Placebo; oral
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-371797, p38 inhibitor; oralDrug
multiple dose, single schedule
Placebo; oralDrug
matching placebo
Placebo; oralDrug
multiple dose, single schedule
| Study group | Role | What they receive |
|---|---|---|
| ARRY-371797 (Schedule 1) | Experimental | Not described Receives: Drug: ARRY-371797, p38 inhibitor; oral |
| ARRY-371797 (Schedule 2) | Experimental | Not described Receives: Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20).
Measured: 12 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: 12 weeks
Secondary outcomes (2)
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Measured: 12 weeks
Explore potential biomarkers for pharmacodynamics (PD).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study start16 Dec 2008
- Primary completion29 Sep 2009
- Study completion29 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 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
- NCT00811499
- Sponsor's protocol ID
- ARRAY-797-201
- Other IDs
- C4411006
- Status last verified
- Oct 2020
- First submitted
- 17 Dec 2008
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00811499
- Acronym / sponsor ID
- ARRAY-797-201
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2008 (actual)
- Primary completion
- 29 Sep 2009 (actual)
- Study completion
- 29 Sep 2009 (actual)
- First posted
- 19 Dec 2008 (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 is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients from the US, Canada, Poland and Hungary will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARRY-371797 (Schedule 1) | Experimental | Drug: ARRY-371797, p38 inhibitor; oral |
| ARRY-371797 (Schedule 2) | Experimental | Drug: ARRY-371797, p38 inhibitor; oral, Drug: Placebo; oral |
| Placebo | Placebo comparator | Drug: Placebo; oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of ankylosing spondylitis according to the Modified New York Criteria (1984).
- Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance.
- If previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug.
- Patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug).
- Additional criteria exist.
Key exclusion criteria (7 listed)
- Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments.
- Previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug.
- Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study.
- Trauma or other major surgeries within 8 weeks prior to first dose of study drug.
- Specific abnormal laboratory values or electrocardiogram abnormalities.
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 |
|---|---|---|
| ARRY-371797, p38 inhibitor; oralmultiple dose, single schedule | Drug | ARRY-371797 (Schedule 1), ARRY-371797 (Schedule 2) |
| Placebo; oralmatching placebo | Drug | Placebo |
| Placebo; oralmultiple dose, single schedule | Drug | ARRY-371797 (Schedule 2) |
Primary outcome
Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20).
Time frame: 12 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: 12 weeks
2 secondary outcomes
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Time frame: 12 weeks
Explore potential biomarkers for pharmacodynamics (PD).
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARRY-371797, p38 inhibitor; oral in people with Ankylosing Spondylitis, run by Pfizer at 12 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 7 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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 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 was stopped early. Results are not available in the source record.
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?
Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20). (time frame: 12 weeks). The study lists 2 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 19 Oct 2020.