Psoriatic ArthritisPhase 3TICOPANCT01106079
TIght COntrol of Psoriatic Arthritis
A Phase 3 study of Psoriatic Arthritis, run by Julia Brown at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate whether tight control of patients with newly diagnosed psoriatic arthritis (consisting of regular 4 weekly objective assessment of disease activity and protocol-led intensive treatment) can improve outcome as opposed to standard care (usually 3 monthly reviews with no… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- May 2008to Jan 2013
- 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
- Patients with a diagnosis of psoriatic arthritis by a consultant Rheumatologist with less than 24 months disease duration.
- Active disease defined by at least one tender or swollen joint or active enthesitis.
- Age ≥18 years at the time of signing the informed consent form and either male or female patients.
- Patient understands the objectives of the study and is able and willing to sign the Informed Consent Form.
- Men and women of child bearing potential (WCBP) must use at least one adequate birth control measure for the duration of the study and should continue such precautions for 6 months after receiving the last dose of protocol treatment.
- Adequate full blood count within 28 days before randomisation:
Show all 13Show fewer
- Haemoglobin count > 8.5 g/dL
- White blood count (WBC) > 3.5 x 10*9/L
- Absolute neutrophil count (ANC) > 1.5 x 10*9/L
- Platelet count > 100 x 10*9/L
- Adequate hepatobiliary function within 28 days before randomisation:
- ALT and/or AST levels must be within 3 times the upper limit of normal range (ULN) for the laboratory conducting the test.
- The patient must be able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide,
- Women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment.
- Use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
St Luke's Hospital
Bradford
Chapel Allerton Hospital
Leeds, West Yorkshire, LS7 4SA
York District Hospital
York
About this study
Official title: A Randomised Controlled Trial to Compare Intensive Management vs Standard Care in Early Psoriatic Arthritis
The purpose of this study is to investigate whether tight control of patients with newly diagnosed psoriatic arthritis (consisting of regular 4 weekly objective assessment of disease activity and protocol-led intensive treatment) can improve outcome as opposed to standard care (usually 3 monthly reviews with no objective outcome measures and no protocol for treatment). The principle hypothesis of this study is that tight control of inflammation in psoriatic arthritis using a treatment protocol and pre-defined objective targets for treatment will lead to an improvement in patients' disease activity and a reduction in radiological joint damage.
Read the detailed description
The TICOPA trial is designed as a randomised, controlled, parallel group, open label, multi-centre clinical trial of 206 patients with recent onset psoriatic arthritis. Patients will be randomised on a 1:1 basis to receive either standard care (12 weekly review) or tight control (4 weekly review) for a period of 48 weeks. The hypothesis is that tight control of inflammation will lead to a better outcome in terms of joint inflammation, joint damage, pain and quality of life for people with PsA. This imaging undertaken within the study will provide a further measure of joint inflammation and damage and will improve understanding of the relationships between inflammation, damage and bony proliferation in psoriatic arthritis.
Those subjects randomised to the tight control arm will be reviewed every 4 weeks (by the PI at each site or a designated researcher), and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate, increasing in dose rapidly over the first 8 weeks of the study. From the 12 week visit onwards, escalation of therapy in this arm will be performed if subjects do not meet the objective target of Minimal Disease Activity. Initial escalation will be to combination DMARD therapy. If patients in the tight control arm fail to meet the MDA criteria and fulfil the NICE criteria for the use of TNF blockers in psoriatic arthritis at 24 weeks, then they will be offered treatment with these medications. Therapy will continue to be modified throughout the 48 week follow-up until a state of minimal disease activity is reached. The control group will be seen every 12 weeks in a general rheumatology clinic and will receive standard care, involving standard DMARDs and biologics as appropriate. Treatment will be prescribed as felt appropriate by the treating physicians with no set protocol and no restrictions.
All subjects will be treated and followed-up for 48 weeks from randomisation according to their treatment allocation and will have 12 weekly clinical disease assessments throughout this period by a fully trained, blinded assessor. This will include measures of disease activity in all of the five aspects of PsA (joint disease, skin disease, enthesitis, dactylitis and spinal disease).
- Conditions
- Psoriatic Arthritis
- Being tested
- Intensive management or Tight control, Standard management - Control group
- Keywords
- Early psoriatic arthritis, Tight control, Intensive management
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive management or Tight controlDrug
Those subjects randomised to the intensive management or tight control arm will be reviewed every 4 weeks (by the Principal Investigator at each site or a designated researcher) and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate, increasing in dose rapidly over the first 8 weeks of the study. From the 12 week visit onwards, escalation of therapy in this arm will be performed if subjects do not meet the objective target of Minimal Disease Activity. Initial escalation will be to combination DMARD therapy. If patients in the tight control arm fail to meet the MDA criteria and fulfil the NICE criteria for the use of TNF blockers in psoriatic arthritis at 24 weeks, then they will be offered treatment with these medications. Therapy will continue to be modified throughout the 48 week follow-up until a state of minimal disease activity is reached.
Standard management - Control groupDrug
The control group will be seen every 12 weeks in a general rheumatology clinic and will receive standard care, involving standard DMARDs and biologics as appropriate. Treatment will be prescribed as felt appropriate by the treating physicians with no set protocol and no restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Intensive management | Experimental | Not described Receives: Drug: Intensive management or Tight control |
| Standard management | Active comparator | Not described Receives: Drug: Standard management - Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving an ACR20 response.
To compare intensive management with standard care in terms of the proportion of patients achieving an ACR20 response at 48 weeks post-randomisation, in order to determine whether intensive management has superior clinical efficacy.
Measured: 48 weeks
Secondary outcomes (9)
Additional clinical efficacy outcomes
To compare intensive management with standard care in terms of additional clinical efficacy outcomes at 24 and 48 weeks, including:
- ACR20 (24 weeks), ACR50 and ACR70
- PASI 20, PASI 75 and PASI 90
- Change in Sharp-van der Heijde Score
- ASAS 20 and ASAS 40
- Change in enthesitis score
- Change in dactylitis score
- Change in mNAPSI
- Change in HAQ
- Change in other scores (including BASDAI, tender and swollen joint counts, patient and clinician VAS scores)
- MDA score
Measured: 24 weeks
Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL
To compare intensive management with standard care in terms of Quality of Life (QoL),using PsAQoL between intensive management and standard care at baseline, 24 and 48 weeks
Measured: 24 weeks
To compare intensive management with standard care in terms of cost effectiveness
To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks
Measured: 12 weeks
Number of participants with adverse events as a measure of safety and tolerability
To compare intensive management with standard care in terms of safety outcomes over the course of the treatment until 52 weeks
Measured: From baseline until 52 weeks
Imaging efficacy: PsAMRIS and ultrasound assessment of disease
To compare intensive management with standard care in terms of imaging efficacy outcomes including change in Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) and ultrasound assessment of disease at 48 weeks in order to assess inflammation and damage.
Measured: 48 weeks
Additional clinical efficacy outcomes
To compare intensive management with standard care in terms of additional clinical efficacy outcomes at 24 and 48 weeks, including:
- ACR20 (24 weeks), ACR50 and ACR70
- PASI 20, PASI 75 and PASI 90
- Change in Sharp-van der Heijde Score
- ASAS 20 and ASAS 40
- Change in enthesitis score
- Change in dactylitis score
- Change in mNAPSI
- Change in HAQ
- Change in other scores (including BASDAI, tender and swollen joint counts, patient and clinician VAS scores)
- MDA score
Measured: 48 weeks
Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL
To compare intensive management with standard care in terms of Quality of Life (QoL),using PsAQoL between intensive management and standard care at baseline, 24 and 48 weeks.
Measured: 48 weeks
To compare intensive management with standard care in terms of cost effectiveness
To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks
Measured: 24 weeks
To compare intensive management with standard care in terms of cost effectiveness
To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startMay 2008
- Primary completionJul 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Psoriatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julia Brown
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK, Pfizer
- Responsible party
- Sponsor-investigator, Julia Brown, University of Leeds
- Investigators
- Philip Helliwell, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106079
- Sponsor's protocol ID
- RR07/8350
- Other IDs
- 2007-004757-28, 18825
- Acronym
- TICOPA
- Status last verified
- May 2015
- First submitted
- 15 Apr 2010
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coates LC, Mahmood F, Emery P, Conaghan PG, Helliwell PS. The dynamics of response as measured by multiple composite outcome tools in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial. Ann Rheum Dis. 2017 Oct;76(10):1688-1692. doi: 10.1136/annrheumdis-2017-211137. Epub 2017 Jun 12.
PubMed 28606970O'Dwyer JL, Meads DM, Hulme CT, Mcparland L, Brown S, Coates LC, Moverley AR, Emery P, Conaghan PG, Helliwell PS. Cost-Effectiveness of Tight Control of Inflammation in Early Psoriatic Arthritis: Economic Analysis of a Multicenter Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Mar;70(3):462-468. doi: 10.1002/acr.23293. Epub 2018 Jan 30.
PubMed 28544822Coates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O'Dwyer JL, Meads DM, Emery P, Conaghan PG, Helliwell PS. Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2489-98. doi: 10.1016/S0140-6736(15)00347-5. Epub 2015 Oct 1.
PubMed 26433318Freeston JE, Coates LC, Nam JL, Moverley AR, Hensor EM, Wakefield RJ, Emery P, Helliwell PS, Conaghan PG. Is there subclinical synovitis in early psoriatic arthritis? A clinical comparison with gray-scale and power Doppler ultrasound. Arthritis Care Res (Hoboken). 2014 Mar;66(3):432-9. doi: 10.1002/acr.22158.
PubMed 24022986Coates LC, Navarro-Coy N, Brown SR, Brown S, McParland L, Collier H, Skinner E, Law J, Moverley A, Pavitt S, Hulme C, Emery P, Conaghan PG, Helliwell PS. The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis. BMC Musculoskelet Disord. 2013 Mar 21;14:101. doi: 10.1186/1471-2474-14-101.
PubMed 23517506
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Compare Intensive Management vs Standard Care in Early Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT01106079
- Acronym / sponsor ID
- TICOPA / RR07/8350
- Conditions
- Psoriatic Arthritis
- Keywords
- Early psoriatic arthritis, Tight control, Intensive management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Julia BrownUniversity, hospital or other
- Collaborators
- Arthritis Research UK, Pfizer
- Study start
- May 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Apr 2010 (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 this study is to investigate whether tight control of patients with newly diagnosed psoriatic arthritis (consisting of regular 4 weekly objective assessment of disease activity and protocol-led intensive treatment) can improve outcome as opposed to standard care (usually 3 monthly reviews with no objective outcome measures and no protocol for treatment). The principle hypothesis of this study is that tight control of inflammation in psoriatic arthritis using a treatment protocol and pre-defined objective targets for treatment will lead to an improvement in patients' disease activity and a reduction in radiological joint damage.
Detailed description
The TICOPA trial is designed as a randomised, controlled, parallel group, open label, multi-centre clinical trial of 206 patients with recent onset psoriatic arthritis. Patients will be randomised on a 1:1 basis to receive either standard care (12 weekly review) or tight control (4 weekly review) for a period of 48 weeks. The hypothesis is that tight control of inflammation will lead to a better outcome in terms of joint inflammation, joint damage, pain and quality of life for people with PsA. This imaging undertaken within the study will provide a further measure of joint inflammation and damage and will improve understanding of the relationships between inflammation, damage and bony proliferation in psoriatic arthritis.
Those subjects randomised to the tight control arm will be reviewed every 4 weeks (by the PI at each site or a designated researcher), and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate, increasing in dose rapidly over the first 8 weeks of the study. From the 12 week visit onwards, escalation of therapy in this arm will be performed if subjects do not meet the objective target of Minimal Disease Activity. Initial escalation will be to combination DMARD therapy. If patients in the tight control arm fail to meet the MDA criteria and fulfil the NICE criteria for the use of TNF blockers in psoriatic arthritis at 24 weeks, then they will be offered treatment with these medications. Therapy will continue to be modified throughout the 48 week follow-up until a state of minimal disease activity is reached. The control group will be seen every 12 weeks in a general rheumatology clinic and will receive standard care, involving standard DMARDs and biologics as appropriate. Treatment will be prescribed as felt appropriate by the treating physicians with no set protocol and no restrictions.
All subjects will be treated and followed-up for 48 weeks from randomisation according to their treatment allocation and will have 12 weekly clinical disease assessments throughout this period by a fully trained, blinded assessor. This will include measures of disease activity in all of the five aspects of PsA (joint disease, skin disease, enthesitis, dactylitis and spinal disease).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive management | Experimental | Drug: Intensive management or Tight control |
| Standard management | Active comparator | Drug: Standard management - Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with a diagnosis of psoriatic arthritis by a consultant Rheumatologist with less than 24 months disease duration.
- Active disease defined by at least one tender or swollen joint or active enthesitis.
- Age ≥18 years at the time of signing the informed consent form and either male or female patients.
- Patient understands the objectives of the study and is able and willing to sign the Informed Consent Form.
- Men and women of child bearing potential (WCBP) must use at least one adequate birth control measure for the duration of the study and should continue such precautions for 6 months after receiving the last dose of protocol treatment.
Key exclusion criteria (3 listed)
- Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide,
- Women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment.
- Use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation.
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 |
|---|---|---|
| Intensive management or Tight controlThose subjects randomised to the intensive management or tight control arm will be reviewed every 4 weeks (by the Principal Investigator at each site or a designated researcher) and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate, increasing in dose rapidly over the first 8 weeks of the study. From the 12 week visit onwards, escalation of therapy in this arm will be performed if subjects do not meet the objective target of Minimal Disease Activity. Initial escalation will be to combination DMARD therapy. If patients in the tight control arm fail to meet the MDA criteria and fulfil the NICE criteria for the use of TNF blockers in psoriatic arthritis at 24 weeks, then they will be offered treatment with these medications. Therapy will continue to be modified throughout the 48 week follow-up until a state of minimal disease activity is reached. | Drug | Intensive management |
| Standard management - Control groupThe control group will be seen every 12 weeks in a general rheumatology clinic and will receive standard care, involving standard DMARDs and biologics as appropriate. Treatment will be prescribed as felt appropriate by the treating physicians with no set protocol and no restrictions. | Drug | Standard management |
Primary outcome
Proportion of patients achieving an ACR20 response.
Time frame: 48 weeks
To compare intensive management with standard care in terms of the proportion of patients achieving an ACR20 response at 48 weeks post-randomisation, in order to determine whether intensive management has superior clinical efficacy.
9 secondary outcomes
Additional clinical efficacy outcomes
Time frame: 24 weeks
Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL
Time frame: 24 weeks
To compare intensive management with standard care in terms of cost effectiveness
Time frame: 12 weeks
Number of participants with adverse events as a measure of safety and tolerability
Time frame: From baseline until 52 weeks
Imaging efficacy: PsAMRIS and ultrasound assessment of disease
Time frame: 48 weeks
Additional clinical efficacy outcomes
Time frame: 48 weeks
Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL
Time frame: 48 weeks
To compare intensive management with standard care in terms of cost effectiveness
Time frame: 24 weeks
To compare intensive management with standard care in terms of cost effectiveness
Time frame: 48 weeks
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 28 May 2015.
- Derived from this study: PubMed 28606970Coates LC, Mahmood F, Emery P, Conaghan PG, Helliwell PS. The dynamics of response as measured by multiple composite outcome tools in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial. Ann Rheum Dis. 2017 Oct;76(10):1688-1692. doi: 10.1136/annrheumdis-2017-211137. Epub 2017 Jun 12.
- Derived from this study: PubMed 28544822O'Dwyer JL, Meads DM, Hulme CT, Mcparland L, Brown S, Coates LC, Moverley AR, Emery P, Conaghan PG, Helliwell PS. Cost-Effectiveness of Tight Control of Inflammation in Early Psoriatic Arthritis: Economic Analysis of a Multicenter Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Mar;70(3):462-468. doi: 10.1002/acr.23293. Epub 2018 Jan 30.
- Derived from this study: PubMed 26433318Coates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O'Dwyer JL, Meads DM, Emery P, Conaghan PG, Helliwell PS. Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2489-98. doi: 10.1016/S0140-6736(15)00347-5. Epub 2015 Oct 1.
- Derived from this study: PubMed 24022986Freeston JE, Coates LC, Nam JL, Moverley AR, Hensor EM, Wakefield RJ, Emery P, Helliwell PS, Conaghan PG. Is there subclinical synovitis in early psoriatic arthritis? A clinical comparison with gray-scale and power Doppler ultrasound. Arthritis Care Res (Hoboken). 2014 Mar;66(3):432-9. doi: 10.1002/acr.22158.
- Derived from this study: PubMed 23517506Coates LC, Navarro-Coy N, Brown SR, Brown S, McParland L, Collier H, Skinner E, Law J, Moverley A, Pavitt S, Hulme C, Emery P, Conaghan PG, Helliwell PS. The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis. BMC Musculoskelet Disord. 2013 Mar 21;14:101. doi: 10.1186/1471-2474-14-101.
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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.
Philip Helliwell principal investigator
University of Leeds
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Psoriatic Arthritis, run by Julia Brown at 3 sites in United Kingdom.
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 13 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 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?
Proportion of patients achieving an ACR20 response. (time frame: 48 weeks). 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 NCT01106079, which also lists 5 linked publications.
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 28 May 2015.