Rheumatoid ArthritisPhase 4NCT00649922
Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
A Phase 4 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott.
Trial summary
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Feb 2005
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Females at least 20 years of age.
- Females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
- Females have a negative pregnancy test at screening.
- Diagnosis of RA and met ACR criteria.
- Must discontinue any TNF at least 2 months prior to baseline.
- In condition of general good health.
Who cannot join
- History of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with Listeria or TB; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
- History of current acute inflammatory joint disease.
- Use of TAMIFLU or Symmetrel within 3 months of study drug administration.
- Recent (3 month) history of influenza or pneumococcal bacterial infection.
- Known positive human immunodeficiency virus (HIV) status.
- Positive hepatitis B or hepatitis C virus.
- Positive PPD >5 mm.
- Chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.
About this study
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
- Conditions
- Rheumatoid Arthritis
- Being tested
- adalimumab, placebo
- Keywords
- Vaccines with adalimumab dosing
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabBiological
Also called ABT-D2E7, Humira
80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
placeboBiological
2 injections Day 1, 1 injection Days 15 and 29
adalimumabBiological
Also called ABT-D2E7, Humira
40 mg adalimumab every other week
| Study group | Role | What they receive |
|---|---|---|
| Double Blind | Placebo comparator | Not described Receives: Biological: adalimumab; Biological: placebo |
| Open Label | Experimental | Not described Receives: Biological: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples for Influenza A & B antibody Assay
Measured: Baseline (Day 1), Day 36 or premature discontinuation
Blood Samples for Pneumococcal Antibody Assay
Measured: Baseline (Day 1), Day 36 or premature discontinuation
Secondary outcomes (3)
Laboratory assessments
Measured: Screening, Week 15, Day 36, Month 3 and Month 6
Vitals signs
Measured: Screening - Month 6
Adverse events
Measured: Screening - Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startOct 2003
- Primary completionDec 2004
- Study completionFeb 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649922
- Sponsor's protocol ID
- M03-600
- Status last verified
- Mar 2008
- First submitted
- 28 Mar 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
PubMed 27338778
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00649922
- Acronym / sponsor ID
- M03-600
- Conditions
- Rheumatoid Arthritis
- Keywords
- Vaccines with adalimumab dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 1 Apr 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.
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
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 |
|---|---|---|
| Double Blind | Placebo comparator | Biological: adalimumab, Biological: placebo |
| Open Label | Experimental | Biological: adalimumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male/Females at least 20 years of age.
- Females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
- Females have a negative pregnancy test at screening.
- Diagnosis of RA and met ACR criteria.
- Must discontinue any TNF at least 2 months prior to baseline.
Key exclusion criteria (8 listed)
- History of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with Listeria or TB; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
- History of current acute inflammatory joint disease.
- Use of TAMIFLU or Symmetrel within 3 months of study drug administration.
- Recent (3 month) history of influenza or pneumococcal bacterial infection.
- Known positive human immunodeficiency virus (HIV) status.
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 |
|---|---|---|
| adalimumabAlso: ABT-D2E7, Humira80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29 | Biological | Double Blind |
| placebo2 injections Day 1, 1 injection Days 15 and 29 | Biological | Double Blind |
| adalimumabAlso: ABT-D2E7, Humira40 mg adalimumab every other week | Biological | Open Label |
Primary outcome
Blood samples for Influenza A & B antibody Assay
Time frame: Baseline (Day 1), Day 36 or premature discontinuation
Blood Samples for Pneumococcal Antibody Assay
Time frame: Baseline (Day 1), Day 36 or premature discontinuation
3 secondary outcomes
Laboratory assessments
Time frame: Screening, Week 15, Day 36, Month 3 and Month 6
Vitals signs
Time frame: Screening - Month 6
Adverse events
Time frame: Screening - Month 6
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 1 Apr 2008.
- Derived from this study: PubMed 27338778Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott.
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 6 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 1 Apr 2008. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Blood samples for Influenza A & B antibody Assay (time frame: Baseline (Day 1), Day 36 or premature discontinuation). 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?
On the ClinicalTrials.gov record for NCT00649922, 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 1 Apr 2008.