Rheumatoid ArthritisPhase 2NCT00293826
A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis
A Phase 2 study testing AMG 108 in people with Rheumatoid Arthritis, run by Amgen.
Trial summary
The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis. 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?
- AMG 108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 813 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Feb 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
- Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening
Who cannot join
- Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
- Presence of serious infection
- Class IV rheumatoid arthritis
- Prior or current history of tuberculosis infection or exposure
- Any other DMARDs other than methotrexate within 6 weeks of screening
- Pregnant or nursing
- Receipt of live vaccines within 3 months
- Felty's syndrome
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.
The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- AMG 108, Placebo
- Keywords
- ACR criteria, methotrexate, DMARDs, patient reported outcomes, joint assessment
- 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
50mg via SC (subcutaneous) injection every 4 weeks
AMG 108Drug
250mg via SC (subcutaneous) injection every 4 weeks
AMG 108Drug
125mg via SC (subcutaneous) injection every 4 weeks
PlaceboDrug
Placebo via SC (subcutaneous) injection every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 196 subjects Receives: Drug: AMG 108 |
| 3 | Experimental | 196 subjects Receives: Drug: AMG 108 |
| 2 | Experimental | 196 subjects Receives: Drug: AMG 108 |
| 4 | Placebo comparator | 196 subjects Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 response
Measured: 24 Weeks
Secondary outcomes (4)
Change in subject reported outcomes
Measured: 24 Weeks
ACRn, AUC ACRn, ACR50, ACR70, and DAS28
Measured: 24 Weeks
PK parameters
Measured: 24 Weeks
Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2007
- Study completionFeb 2008
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.
- 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
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293826
- Sponsor's protocol ID
- 20050168
- Status last verified
- Mar 2010
- First submitted
- 17 Feb 2006
- Last updated
- 5 Mar 2010
- Results posted
- No
Publications
Cardiel MH, Tak PP, Bensen W, Burch FX, Forejtova S, Badurski JE, Kakkar T, Bevirt T, Ni L, McCroskery E, Jahreis A, Zack DJ. A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis. Arthritis Res Ther. 2010;12(5):R192. doi: 10.1186/ar3163. Epub 2010 Oct 15.
PubMed 20950476
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00293826
- Acronym / sponsor ID
- 20050168
- Conditions
- Rheumatoid Arthritis
- Keywords
- ACR criteria, methotrexate, DMARDs, patient reported outcomes, joint assessment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 813 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Feb 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 determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AMG 108196 subjects |
| 3 | Experimental | Drug: AMG 108196 subjects |
| 2 | Experimental | Drug: AMG 108196 subjects |
| 4 | Placebo comparator | Drug: Placebo196 subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
- Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening
Key exclusion criteria (8 listed)
- Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
- Presence of serious infection
- Class IV rheumatoid arthritis
- Prior or current history of tuberculosis infection or exposure
- Any other DMARDs other than methotrexate within 6 weeks of screening
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 10850mg via SC (subcutaneous) injection every 4 weeks | Drug | 1 |
| AMG 108250mg via SC (subcutaneous) injection every 4 weeks | Drug | 3 |
| AMG 108125mg via SC (subcutaneous) injection every 4 weeks | Drug | 2 |
| PlaceboPlacebo via SC (subcutaneous) injection every 4 weeks | Drug | 4 |
Primary outcome
ACR20 response
Time frame: 24 Weeks
4 secondary outcomes
Change in subject reported outcomes
Time frame: 24 Weeks
ACRn, AUC ACRn, ACR50, ACR70, and DAS28
Time frame: 24 Weeks
PK parameters
Time frame: 24 Weeks
Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status
Time frame: 24 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 5 Mar 2010.
- Derived from this study: PubMed 20950476Cardiel MH, Tak PP, Bensen W, Burch FX, Forejtova S, Badurski JE, Kakkar T, Bevirt T, Ni L, McCroskery E, Jahreis A, Zack DJ. A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis. Arthritis Res Ther. 2010;12(5):R192. doi: 10.1186/ar3163. Epub 2010 Oct 15.
- 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 2 inclusion and 8 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 5 Mar 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. 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 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?
ACR20 response (time frame: 24 Weeks). 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 NCT00293826, 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 5 Mar 2010.