Rheumatoid ArthritisPhase 1NCT00771329
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
A Phase 1 study testing BIIB023 in people with Rheumatoid Arthritis, run by Biogen at 6 sites in 2 countries.
Trial summary
Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- BIIB023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2008to Apr 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of adult onset RA (functional class I-III) for at least 6 months
- Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
- Must have at least 4 swollen and tender joints due to rheumatoid arthritis
Who cannot join
- History of recurrent infections requiring antibiotic treatment within 12 months
- Serious local infection or systemic infection within 3 months
- Suffering from rheumatic or autoimmune disease other than RA
- History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Research Site
Anniston, Alabama
Research Centre
Duncansville, Pennsylvania
Research Site
Oklahoma City, Oklahoma
Research Centre
Palm Desert, California
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.
Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.
- Conditions
- Rheumatoid Arthritis
- Being tested
- BIIB023, Placebo (sterile normal saline)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB023Drug
Also called Human glycosylated IgG1 monoclonal antibody
Single IV doses of BIIB023 in dose-escalating cohorts
Placebo (sterile normal saline)Other
Single IV dose of Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BIIB023 Receives: Drug: BIIB023 |
| 2 | Placebo comparator | Not described Receives: Other: Placebo (sterile normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
Measured: Baseline through Day 70
Secondary outcomes (1)
• Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects
Measured: Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2011
- Study completionApr 2011
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 BiogenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771329
- Sponsor's protocol ID
- 211RA101
- Status last verified
- May 2011
- First submitted
- 10 Oct 2008
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wisniacki N, Amaravadi L, Galluppi GR, Zheng TS, Zhang R, Kong J, Burkly LC. Safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-TWEAK monoclonal antibody in patients with rheumatoid arthritis. Clin Ther. 2013 Aug;35(8):1137-49. doi: 10.1016/j.clinthera.2013.06.008. Epub 2013 Aug 6.
PubMed 23928094
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00771329
- Acronym / sponsor ID
- 211RA101
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Oct 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.
Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.
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: BIIB023BIIB023 |
| 2 | Placebo comparator | Other: Placebo (sterile normal saline) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of adult onset RA (functional class I-III) for at least 6 months
- Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
- Must have at least 4 swollen and tender joints due to rheumatoid arthritis
Key exclusion criteria (4 listed)
- History of recurrent infections requiring antibiotic treatment within 12 months
- Serious local infection or systemic infection within 3 months
- Suffering from rheumatic or autoimmune disease other than RA
- History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness
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 |
|---|---|---|
| BIIB023Also: Human glycosylated IgG1 monoclonal antibodySingle IV doses of BIIB023 in dose-escalating cohorts | Drug | 1 |
| Placebo (sterile normal saline)Single IV dose of Placebo | Other | 2 |
Primary outcome
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
Time frame: Baseline through Day 70
1 secondary outcome
• Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects
Time frame: Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70
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 16 Sep 2013.
- Derived from this study: PubMed 23928094Wisniacki N, Amaravadi L, Galluppi GR, Zheng TS, Zhang R, Kong J, Burkly LC. Safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-TWEAK monoclonal antibody in patients with rheumatoid arthritis. Clin Ther. 2013 Aug;35(8):1137-49. doi: 10.1016/j.clinthera.2013.06.008. Epub 2013 Aug 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB023 in people with Rheumatoid Arthritis, run by Biogen at 6 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 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Russia. 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 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.
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?
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA. (time frame: Baseline through Day 70). 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 NCT00771329, 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 16 Sep 2013.