Rheumatoid ArthritisPhase 1/2NCT00411424
Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis
A Phase 1/2 study testing ASK8007 in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 10 sites in 6 countries.
Trial summary
The purpose of this study is to investigate the safety and tolerability of the new medication ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ASK8007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Sep 2007to Jun 2009
- Phase
- Phase 1/2
- 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
- meet the American Rheumatism Association (ARA) 1987 revised criteria for the classification of RA (also referred to as the American College of Rheumatology [ACR] criteria);
- being treated with an adequate dose (to the discretion of the local physicians) of either MTX or leflunomide (LEF)or sulfasalazine (SS2) for at least 4 months prior to baseline of which the last 6 weeks before baseline were at a stable dose;
- have active poly-arthritis (i.e. active rheumatoid arthritis as defined in detail in the protocol)
Who cannot join
- have been treated with any registered or non-registered investigational drug in the context of a clinical intervention study during the last 3 months before baseline;
- have been treated with TNFα-blockers within a certain period of time (defined for each medication) before baseline;
- have been treated with any DMARD other than MTX, LEF or SS2 during the last month before baseline;
- documented evidence for the presence of clinically severe, unstable, or uncontrollable renal, hepatic, respiratory, hematological, genitourinary, cardiovascular, endocrine, neurological, psychiatric, or other medical illness which would, in the opinion of the investigator, put the patient at safety risk or mask measures of efficacy.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
About this study
Official title: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of ASK8007 in Comparison With Placebo in Patients With Active Rheumatoid Arthritis - a Randomized, Double Blind, Placebo-controlled, Combined Single Dose Escalation and Multiple Dose Study
The purpose of this study is to investigate the safety and tolerability of the new medication ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ASK8007, Placebo
- Keywords
- Rheumatoid Arthritis, Randomized Control Trial, Treatment outcomes, Monoclonal antibody
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASK8007Drug
IV
PlaceboDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ASK8007 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability MD ASK8007
Measured: up to 10 weeks after last dose
Secondary outcomes (1)
DAS28+CD68
Measured: Day 43 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startSep 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411424
- Sponsor's protocol ID
- 8007-CL-0001
- Other IDs
- EudraCT number: 2006-000172-33
- Status last verified
- Mar 2013
- First submitted
- 12 Dec 2006
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Boumans MJ, Houbiers JG, Verschueren P, Ishikura H, Westhovens R, Brouwer E, Rojkovich B, Kelly S, den Adel M, Isaacs J, Jacobs H, Gomez-Reino J, Holtkamp GM, Hastings A, Gerlag DM, Tak PP. Safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of the monoclonal antibody ASK8007 blocking osteopontin in patients with rheumatoid arthritis: a randomised, placebo controlled, proof-of-concept study. Ann Rheum Dis. 2012 Feb;71(2):180-5. doi: 10.1136/annrheumdis-2011-200298. Epub 2011 Sep 14.
PubMed 21917822
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of ASK8007 in Comparison With Placebo in Patients With Active Rheumatoid Arthritis - a Randomized, Double Blind, Placebo-controlled, Combined Single Dose Escalation and Multiple Dose Study
- ClinicalTrials.gov ID
- NCT00411424
- Acronym / sponsor ID
- 8007-CL-0001
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Randomized Control Trial, Treatment outcomes, Monoclonal antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Dec 2006 (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 investigate the safety and tolerability of the new medication ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ASK8007 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- meet the American Rheumatism Association (ARA) 1987 revised criteria for the classification of RA (also referred to as the American College of Rheumatology [ACR] criteria);
- being treated with an adequate dose (to the discretion of the local physicians) of either MTX or leflunomide (LEF)or sulfasalazine (SS2) for at least 4 months prior to baseline of which the last 6 weeks before baseline were at a stable dose;
- have active poly-arthritis (i.e. active rheumatoid arthritis as defined in detail in the protocol)
Key exclusion criteria (4 listed)
- have been treated with any registered or non-registered investigational drug in the context of a clinical intervention study during the last 3 months before baseline;
- have been treated with TNFα-blockers within a certain period of time (defined for each medication) before baseline;
- have been treated with any DMARD other than MTX, LEF or SS2 during the last month before baseline;
- documented evidence for the presence of clinically severe, unstable, or uncontrollable renal, hepatic, respiratory, hematological, genitourinary, cardiovascular, endocrine, neurological, psychiatric, or other medical illness which would, in the opinion of the investigator, put the patient at safety risk or mask measures of efficacy.
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 |
|---|---|---|
| ASK8007IV | Drug | 1 |
| PlaceboIV | Drug | 2 |
Primary outcome
Safety and tolerability MD ASK8007
Time frame: up to 10 weeks after last dose
1 secondary outcome
DAS28+CD68
Time frame: Day 43 compared to baseline
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 21 Mar 2013.
- Background: PubMed 21917822Boumans MJ, Houbiers JG, Verschueren P, Ishikura H, Westhovens R, Brouwer E, Rojkovich B, Kelly S, den Adel M, Isaacs J, Jacobs H, Gomez-Reino J, Holtkamp GM, Hastings A, Gerlag DM, Tak PP. Safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of the monoclonal antibody ASK8007 blocking osteopontin in patients with rheumatoid arthritis: a randomised, placebo controlled, proof-of-concept study. Ann Rheum Dis. 2012 Feb;71(2):180-5. doi: 10.1136/annrheumdis-2011-200298. Epub 2011 Sep 14.
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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.
Use Central Contact study director
Astellas Pharma Europe B.V.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASK8007 in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 10 sites in 6 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 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: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Netherlands, United Kingdom, Belgium, Hungary and 1 more country. 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 combined 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.
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?
Safety and tolerability MD ASK8007 (time frame: up to 10 weeks after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00411424, which also lists 1 linked publication.
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 21 Mar 2013.