Rheumatoid ArthritisPhase 2NCT00369473
Long-Term Assessment of Safety and Physical Function With AMG 108 in RA
A Phase 2 study testing AMG 108 in people with Rheumatoid Arthritis, run by Amgen.
Trial summary
The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA 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?
- AMG 108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jun 2008
- 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
- Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll.
Who cannot join
- Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.
About this study
Official title: A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis
The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA
- Conditions
- Rheumatoid Arthritis
- Being tested
- AMG 108
- Keywords
- 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.
AMG 108Drug
125 mg via SC (subcutaneous) injection every 4 weeks
AMG 108Drug
250 mg via SC (subcutaneous) injection every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 350 Receives: Drug: AMG 108 |
| 2 | Experimental | 350 Receives: Drug: AMG 108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
Measured: 144 Weeks
Secondary outcomes (1)
To determine whether long-term use of AMG 108 improves function in subjects with RA
Measured: 144 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
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 AmgenThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369473
- Sponsor's protocol ID
- 20060119
- Status last verified
- Dec 2016
- First submitted
- 24 Aug 2006
- Last updated
- 13 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00369473
- Acronym / sponsor ID
- 20060119
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Aug 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 assess long-term safety of SC AMG 108 in the treatment of RA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AMG 108350 |
| 2 | Experimental | Drug: AMG 108350 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll.
Key exclusion criteria (1 listed)
- Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.
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 |
|---|---|---|
| AMG 108125 mg via SC (subcutaneous) injection every 4 weeks | Drug | 1 |
| AMG 108250 mg via SC (subcutaneous) injection every 4 weeks | Drug | 2 |
Primary outcome
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
Time frame: 144 Weeks
1 secondary outcome
To determine whether long-term use of AMG 108 improves function in subjects with RA
Time frame: 144 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 13 Dec 2016.
- AmgenTrials clinical trials websiteLink 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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 108 in people with Rheumatoid Arthritis, run by Amgen.
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 1 inclusion and 1 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 13 Dec 2016. 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 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?
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168 (time frame: 144 Weeks). 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 13 Dec 2016.