Arthritis, Juvenile RheumatoidNCT01412021
Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis
An observational study of Arthritis, Juvenile Rheumatoid, run by AbbVie.
Trial summary
This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug: Unknown adverse drug reactions (especially important adverse drug reactions) Incidence and conditions of occurrence of adverse reactions in the… Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Arthritis, Juvenile Rheumatoid
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2011to 2 Apr 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who receive Humira for the treatment of Juvenile idiopathic arthritis
Who may be able to join
- All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey
Who cannot join
- Contraindications according to the Package Insert
- Patients who have serious infections
- Patients who have tuberculosis
- Patients with a history of hypersensitivity to any ingredient of Humira
- Patients who have demyelinating disease or with a history of demyelinating disease
- Patients who have congestive cardiac failure
About this study
Official title: Humira® for Subcutaneous Injection Special Investigation ( All-case Survey ) in Patients With Juvenile Idiopathic Arthritis Study
This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug:
- Unknown adverse drug reactions (especially important adverse drug reactions)
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Humira
- Conditions
- Arthritis, Juvenile Rheumatoid
- Keywords
- Arthritis, Juvenile Rheumatoid
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Humira | Participants with juvenile idiopathic arthritis who received Humira (adalimumab). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in DAS28-4/ESR at Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 4
Change From Baseline in DAS28-4/ESR at Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 8
Change From Baseline in DAS28-4/ESR at Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 12
Change From Baseline in DAS28-4/ESR at Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 16
Change From Baseline in DAS28-4/ESR at Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 24
Change From Baseline in DAS28-4/CRP at Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 4
Change From Baseline in DAS28-4/CRP at Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 8
Change From Baseline in DAS28-4/CRP at Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 12
Change From Baseline in DAS28-4/CRP at Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 16
Change From Baseline in DAS28-4/CRP at Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 24
Change From Baseline in Serum MMP3 Level at Week 4
Measured: Baseline, Week 4
Change From Baseline in Serum MMP3 Level at Week 8
Measured: Baseline, Week 8
Change From Baseline in Serum MMP3 Level at Week 12
Measured: Baseline, Week 12
Change From Baseline in Serum MMP3 Level at Week 16
Measured: Baseline, Week 16
Change From Baseline in Serum MMP3 Level at Week 24
Measured: Baseline, Week 24
Change From Baseline in Physician Global Assessment (VAS) at Week 4
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 4
Change From Baseline in Physician Global Assessment (VAS) at Week 8
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 8
Change From Baseline in Physician Global Assessment (VAS) at Week 12
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Change From Baseline in Physician Global Assessment (VAS) at Week 16
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 16
Change From Baseline in Physician Global Assessment (VAS) at Week 24
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 24
Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24
Measured: Baseline, Week 24
Change From Baseline in Height at Week 4
Measured: Baseline, Week 4
Change From Baseline in Height at Week 8
Measured: Baseline, Week 8
Change From Baseline in Height at Week 12
Measured: Baseline, Week 12
Change From Baseline in Height at Week 16
Measured: Baseline, Week 16
Change From Baseline in Height at Week 24
Measured: Baseline, Week 24
Change From Baseline in Weight at Week 4
Measured: Baseline, Week 4
Change From Baseline in Weight at Week 8
Measured: Baseline, Week 8
Change From Baseline in Weight at Week 12
Measured: Baseline, Week 12
Change From Baseline in Weight at Week 16
Measured: Baseline, Week 16
Change From Baseline in Weight at Week 24
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study start1 Jul 2011
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis, Juvenile RheumatoidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412021
- Sponsor's protocol ID
- P12-769
- Status last verified
- Jan 2019
- First submitted
- 5 Aug 2011
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humira® for Subcutaneous Injection Special Investigation ( All-case Survey ) in Patients With Juvenile Idiopathic Arthritis Study
- ClinicalTrials.gov ID
- NCT01412021
- Acronym / sponsor ID
- P12-769
- Conditions
- Arthritis, Juvenile Rheumatoid
- Keywords
- Arthritis, Juvenile Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Posted 8 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug:
- Unknown adverse drug reactions (especially important adverse drug reactions)
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Humira
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Humira | – | –Participants with juvenile idiopathic arthritis who received Humira (adalimumab). |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who receive Humira for the treatment of Juvenile idiopathic arthritis
Key inclusion criteria (1 listed)
- All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey
Key exclusion criteria (6 listed)
- Contraindications according to the Package Insert
- Patients who have serious infections
- Patients who have tuberculosis
- Patients with a history of hypersensitivity to any ingredient of Humira
- Patients who have demyelinating disease or with a history of demyelinating disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in DAS28-4/ESR at Week 4
Time frame: Baseline, Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 8
Time frame: Baseline, Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 12
Time frame: Baseline, Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 16
Time frame: Baseline, Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 24
Time frame: Baseline, Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 4
Time frame: Baseline, Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 8
Time frame: Baseline, Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 12
Time frame: Baseline, Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 16
Time frame: Baseline, Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 24
Time frame: Baseline, Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in Serum MMP3 Level at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Serum MMP3 Level at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Serum MMP3 Level at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Serum MMP3 Level at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Serum MMP3 Level at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Physician Global Assessment (VAS) at Week 4
Time frame: Baseline, Week 4
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 8
Time frame: Baseline, Week 8
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 12
Time frame: Baseline, Week 12
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 16
Time frame: Baseline, Week 16
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 24
Time frame: Baseline, Week 24
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Height at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Height at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Height at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Height at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Height at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Weight at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Weight at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Weight at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Weight at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Weight at Week 24
Time frame: Baseline, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Package Insert InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
AbbVie Inc. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Juvenile Rheumatoid, run by AbbVie.
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 1 inclusion and 6 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 8 Aug 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in DAS28-4/ESR at Week 4 (time frame: Baseline, Week 4). The study lists 31 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 8 Aug 2019.