Rheumatoid ArthritisPhase 1NCT00650156
Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis
A Phase 1 study testing adalimumab in people with Rheumatoid Arthritis, run by AbbVie at 1 site in China.
Trial summary
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild 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?
- adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Jun 2007to Oct 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female ages 18 years and older.
- Mild RA.
- Body weight less than 100 kg.
Who cannot join
- Wheelchair-bound or bedridden.
- Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit.
- Intra-articular, intramuscular or intravenous (IV) administration of corticosteroids within 28 days prior to the Screening visit.
- Prior treatment with any TNF antagonist, including adalimumab.
- Positive tuberculin PPD 5.
- Female subjects who are pregnant or breast-feeding.
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- History of HIV or of being immuno-compromised.
- History of malignancy.
- Poorly controlled medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Being tested
- adalimumab
- 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
40 mg single sc dose
adalimumabBiological
Also called ABT-D2E7, Humira
80 mg single sc dose
| Study group | Role | What they receive |
|---|---|---|
| 40 mg adalimumab | Experimental | Not described Receives: Biological: adalimumab |
| 80 mg Adalimumab | Experimental | Not described Receives: Biological: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
Measured: Days 1, 2, 4, 6, 8, 11, 15, 22, & 29
Secondary outcomes (3)
Adverse event profile
Measured: follow up to day 70 after dose
VAS assessments
Measured: Days 1, 15 and 29
Swollen and Tender Joint counts
Measured: Days 1, 15 and 29
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 startJun 2007
- Primary completionOct 2007
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 AbbVieThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Laura Redden, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650156
- Sponsor's protocol ID
- M10-017
- Status last verified
- Sep 2010
- First submitted
- 28 Mar 2008
- Last updated
- 20 Nov 2017
- 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 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00650156
- Acronym / sponsor ID
- M10-017
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2007 (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.
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 mg adalimumab | Experimental | Biological: adalimumab |
| 80 mg Adalimumab | Experimental | Biological: adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female ages 18 years and older.
- Mild RA.
- Body weight less than 100 kg.
Key exclusion criteria (9 listed)
- Wheelchair-bound or bedridden.
- Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit.
- Intra-articular, intramuscular or intravenous (IV) administration of corticosteroids within 28 days prior to the Screening visit.
- Prior treatment with any TNF antagonist, including adalimumab.
- Positive tuberculin PPD 5.
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, Humira40 mg single sc dose | Biological | 40 mg adalimumab |
| adalimumabAlso: ABT-D2E7, Humira80 mg single sc dose | Biological | 80 mg Adalimumab |
Primary outcome
pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
Time frame: Days 1, 2, 4, 6, 8, 11, 15, 22, & 29
3 secondary outcomes
Adverse event profile
Time frame: follow up to day 70 after dose
VAS assessments
Time frame: Days 1, 15 and 29
Swollen and Tender Joint counts
Time frame: Days 1, 15 and 29
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 20 Nov 2017.
- Background: 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.
Laura Redden, MD study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing adalimumab in people with Rheumatoid Arthritis, run by AbbVie at 1 site in China.
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 9 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab (time frame: Days 1, 2, 4, 6, 8, 11, 15, 22, & 29). 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 NCT00650156, 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 20 Nov 2017.