Rheumatoid ArthritisPhase 2NCT00537667
The SPECTRA Study
A Phase 2 study testing anakinra and anakinra and PEG sTNF-R1 in people with Rheumatoid Arthritis, run by Amgen.
Trial summary
The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects 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?
- anakinra and anakinra and PEG sTNF-R1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Jun 2003
- 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
- Diagnosed with RA as determined by American College of Rheumatology (ACR) criteria (Appendix C)
- Disease duration of no less than 12 weeks of diagnosis confirmed by physician and source documentation
- Disease duration < 10 years
- Active RA at baseline as defined by a minimum of 6 or more swollen joints and 9 or more tender/painful joints (based on a 66/68-joint count excluding distal interphalangeal joints) at screening and baseline,
- And
- C-reactive protein (CRP) > 2 mg/dL at screening.
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- Have active clinical synovitis in the knee as determined by the investigator based on clinical evaluation
- 18 years of age or older
- Men or non-pregnant (negative serum HCG at screening unless surgically sterile or postmenopausal), non-breast-feeding women may be enrolled. Females of childbearing potential and males must use adequate contraceptive precautions as determined by the principal investigator.
- Subjects that have taken any DMARD for less than 3 months must not have taken DMARDs within 4 weeks prior to screening. Subjects that have taken any DMARD for longer than 3 months must not have taken DMARDs within 6 months of screening.
- Subject's doses of NSAIDs and oral corticosteroids (10 mg/day of prednisone or equivalent) must have been kept stable for 4 weeks before screening
- Subjects must not have had intrarticular injections in the joint that will be arthroscoped for at least 3 months prior to screening.
- Before any study specific procedure or screening is done, the subject or legally acceptable representative must give informed consent for participation in the study (see Section 12.2). Before buccal smears and blood samples are taken for genetic testing, the subject or legally acceptable representative must give informed consent for use of those samples for genetic testing (see Section 12.2).
Who cannot join
- ACR functional class IV or American Rheumatology Association anatomical stage IV (see Appendix C)
- Disease duration >10 years
- Diagnosed with the following:
- Felty's syndrome
- Advanced or uncontrolled Diabetes Mellitus (defined as: HbA1c > 8%, peripheral neuropathy, renal/retinal involvement, or vascular disorders)
- Malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, within the past five years
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- Any other major chronic inflammatory disease or syndrome (e.g., psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease, fibromyalgia that required treatment in the last year)
- Any uncontrolled, clinically significant systemic disease
- Pre-existing or recent onset central nervous system demyelinating disorders
- Significant hematologic abnormalities
- A history of drug or alcohol abuse within the previous 24 weeks
- Known to be hepatitis B surface antigen, hepatitis C virus or Human Immunodeficiency Virus positive
- Any disorder that compromises ability to give informed consent for participation in this study
- Is expected to require a major surgical operation while on study that would interfere with the collection of the required assessments.
- Has an infection requiring systemic anti-infective therapy, open wounds, or has developed frequent acute or chronic infections during the past 12 weeks.
- Prior active tuberculosis.
- Total white blood cell count < 3.5 x 109/L at screening
- Neutrophil count of < 2.5 x 109/L at screening
- Platelet count of < 125 x 109/L at screening
- Hemoglobin < 8.0 g/dL at screening
- Abnormal liver function tests (AST/ALT > 1.5 x the upper limits of normal) at screening
- Abnormal renal function (serum creatinine > 1.5 x the upper limits of normal) at screening
- Prior treatment with any protein-based TNF inhibitor (e.g. etanercept, infliximab, PEG sTNF-RI, D2E7)
- Prior treatment with anakinra
- Receiving or has received any investigational drug within the previous 16 weeks or within at least 5 half-lives of any investigational drug, whichever is greater (or is currently using an investigational device)
- Received any intra-articular injections (e.g.. corticosteroids, hyaluronate preparations) or systemic corticosteroid injections within 4 weeks before the screening visit
- Requires analgesia other than paracetamol, NSAIDs, codeine, oxycodone, propoxyphene, tramadol, hydrocodone, or the combinations of these products (or equivalents)
- Subject (men or women of childbearing potential) is not using adequate contraceptive precautions as determined by the principal investigator
- Known allergy to E coli-derived products
- Not available for follow-up assessments
- Concerns for the subject's compliance with the protocol procedures
About this study
Official title: A Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis.
The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- anakinra, anakinra and PEG sTNF-R1
- Keywords
- IL-1ra, PEG sTNF-RI, Synovial biopsy, Inflammation, Bone and Cartilage Destruction, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anakinraDrug
anakinra
anakinra and PEG sTNF-R1Drug
anakinra and PEG sTNF-R1
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | anakinra Receives: Drug: anakinra |
| B | Experimental | anakinra and PEGsTNF-R1 Receives: Drug: anakinra and PEG sTNF-R1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint is the change from baseline at weeks 4, 26 and 52 in levels of select markers of inflammation (CD3 and CD 68) and destruction (MMP-1 and TIMP-1) in the synovium
Measured: up to 52 weeks
Primary safety endpoint is the crude and exposure adjusted subject incidence and nature, frequency, severity, relationship to treatment, and outcome of all adverse events
Measured: up to 52 weeks
Secondary outcomes (2)
Secondary efficacy endpoints are change from baseline at week 4 and 52 in selected markers of bone and cartilage degradation and inflammation
Measured: up to 52 weeks
Secondary safety endpoints are changes from baseline in laboratory parameters
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startAug 2001
- Primary completionMar 2003
- Study completionJun 2003
Why it stopped: The safety profile of combination therapy became unacceptable.
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
- None (open label)
- Enrolment
- 22 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
- NCT00537667
- Sponsor's protocol ID
- 20000211
- Status last verified
- Dec 2008
- First submitted
- 27 Sep 2007
- Last updated
- 26 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00537667
- Acronym / sponsor ID
- 20000211
- Conditions
- Rheumatoid Arthritis
- Keywords
- IL-1ra, PEG sTNF-RI, Synovial biopsy, Inflammation, Bone and Cartilage Destruction, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The safety profile of combination therapy became unacceptable.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Mar 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 1 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.
The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: anakinraanakinra |
| B | Experimental | Drug: anakinra and PEG sTNF-R1anakinra and PEGsTNF-R1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosed with RA as determined by American College of Rheumatology (ACR) criteria (Appendix C)
- Disease duration of no less than 12 weeks of diagnosis confirmed by physician and source documentation
- Disease duration < 10 years
- Active RA at baseline as defined by a minimum of 6 or more swollen joints and 9 or more tender/painful joints (based on a 66/68-joint count excluding distal interphalangeal joints) at screening and baseline,
- And
Key exclusion criteria (31 listed)
- ACR functional class IV or American Rheumatology Association anatomical stage IV (see Appendix C)
- Disease duration >10 years
- Diagnosed with the following:
- Felty's syndrome
- Advanced or uncontrolled Diabetes Mellitus (defined as: HbA1c > 8%, peripheral neuropathy, renal/retinal involvement, or vascular disorders)
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 |
|---|---|---|
| anakinraanakinra | Drug | A |
| anakinra and PEG sTNF-R1anakinra and PEG sTNF-R1 | Drug | B |
Primary outcome
Primary efficacy endpoint is the change from baseline at weeks 4, 26 and 52 in levels of select markers of inflammation (CD3 and CD 68) and destruction (MMP-1 and TIMP-1) in the synovium
Time frame: up to 52 weeks
Primary safety endpoint is the crude and exposure adjusted subject incidence and nature, frequency, severity, relationship to treatment, and outcome of all adverse events
Time frame: up to 52 weeks
2 secondary outcomes
Secondary efficacy endpoints are change from baseline at week 4 and 52 in selected markers of bone and cartilage degradation and inflammation
Time frame: up to 52 weeks
Secondary safety endpoints are changes from baseline in laboratory parameters
Time frame: up to 52 weeks
Results and safety
The study was stopped early (reason given: The safety profile of combination therapy became unacceptable.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2009.
- FDA-approved Drug LabelingLink provided by the sponsor.
- 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 anakinra and anakinra and PEG sTNF-R1 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 13 inclusion and 31 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 26 Nov 2009. 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 was stopped early (reason given: The safety profile of combination therapy became unacceptable.). 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?
Primary efficacy endpoint is the change from baseline at weeks 4, 26 and 52 in levels of select markers of inflammation (CD3 and CD 68) and destruction (MMP-1 and TIMP-1) in the synovium (time frame: up to 52 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 26 Nov 2009.