Rheumatoid ArthritisPhase 3NCT00233571
A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
A Phase 3 study testing Adalimumab 40 mg subcutaneous (SC) every other week (EOW) in people with Rheumatoid Arthritis, run by Abbott.
Trial summary
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients 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?
- Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 796 participants
- Where
- No sites listed yet
- Study dates
- Jun 2000to Jun 2006
- Phase
- Phase 3
- 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
- Completion of a previous D2E7 study
- Subject is in good health (Investigator discretion) with a recent stable medical history
Who cannot join
- Former enrollment in this trial (DE018)
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast feeding or considering becoming pregnant.
About this study
Official title: A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis
- Conditions
- Rheumatoid Arthritis
- Being tested
- Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab 40 mg subcutaneous (SC) every other week (EOW)Biological
Also called ABT-D2E7, adalimumab, Humira
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab 40mg subcutaneous (SC) every other week (EOW) | Experimental | Adalimumab 40mg subcutaneous (SC) every other week (EOW) Receives: Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response indicators
Measured: 5 years
Secondary outcomes (1)
Safety parameters
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startJun 2000
- Primary completionJun 2006
- Study completionJun 2006
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hartmut Kupper, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233571
- Sponsor's protocol ID
- DE018
- Status last verified
- Nov 2011
- First submitted
- 13 Sep 2005
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)
- ClinicalTrials.gov ID
- NCT00233571
- Acronym / sponsor ID
- DE018
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 6 Oct 2005 (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 the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab 40mg subcutaneous (SC) every other week (EOW) | Experimental | Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)Adalimumab 40mg subcutaneous (SC) every other week (EOW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completion of a previous D2E7 study
- Subject is in good health (Investigator discretion) with a recent stable medical history
Key exclusion criteria (3 listed)
- Former enrollment in this trial (DE018)
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast feeding or considering becoming pregnant.
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 |
|---|---|---|
| Adalimumab 40 mg subcutaneous (SC) every other week (EOW)Also: ABT-D2E7, adalimumab, Humira | Biological | Adalimumab 40mg subcutaneous (SC) every other week (EOW) |
Primary outcome
Clinical response indicators
Time frame: 5 years
1 secondary outcome
Safety parameters
Time frame: 5 years
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 22 Nov 2011.
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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.
Hartmut Kupper, MD study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab 40 mg subcutaneous (SC) every other week (EOW) 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 2 inclusion and 3 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 22 Nov 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical response indicators (time frame: 5 years). 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 22 Nov 2011; AzTrials last refreshed its copy on 1 Nov 2026.