Rheumatoid ArthritisPhase 4NCT01119859
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
A Phase 4 study testing Tocilizumab and Adalimumab in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 82 sites in 15 countries.
Trial summary
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. 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?
- Tocilizumab and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 82 sitesin 15 countries
- Study dates
- May 2010to Jan 2012
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, ≥ 18 years of age.
- Rheumatoid arthritis of > 6 months duration.
- Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
- All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
- Weight ≤ 150 kg.
Who cannot join
- Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
- History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
- Treatment with a biologic agent at any time prior to baseline.
- Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
- Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.
Trial locations and contacts
82 sites in 15 countries.
82 sites in 15 countries
United States33 sites
Study site
Anniston, Alabama, 36207
Study site
Birmingham, Alabama, 35294
Study site
Boca Raton, Florida, 33486
Study site
Colorado Springs, Colorado, 80910
Study site
Cumberland, Maryland, 21502
Study site
Dayton, Ohio, 45402
Study site
Dover, New Hampshire, 03820
Study site
Duncansville, Pennsylvania, 16635
Study site
Flowood, Mississippi, 39232
Study site
Fort Lauderdale, Florida, 33334
Study site
Greenville, South Carolina, 29601
Study site
Hickory, North Carolina, 28601
Study site
Hixson, Tennessee, 37343
Study site
Hot Springs, Arkansas, 71913
Study site
Houston, Texas, 77074
Study site
Idaho Falls, Idaho, 83404
Study site
Lincoln, Nebraska, 68516
Study site
Little Rock, Arkansas, 72205
Study site
Lubbock, Texas, 79424
Study site
Mesquite, Texas, 75150
Study site
Nassau Bay, Texas, 77058
Study site
New Brunswick, New Jersey, 08903
Study site
Ormond Beach, Florida, 32174
Study site
San Diego, California, 92108
Study site
Scottsdale, Arizona, 85258
Study site
Spokane, Washington, 99204
Study site
Springfield, Illinois, 62704
Study site
Tacoma, Washington, 98405
Study site
Trumbull, Connecticut, 06611
Study site
Tupelo, Mississippi, 38802
Study site
Waco, Texas, 76708
Study site
Willow Grove, Pennsylvania, 19090
Study site
Wyomissing, Pennsylvania, 19610
Germany10 sites
Study site
Baden-Baden, 76530
Study site
Berlin, 14059
Study site
Cologne, 50924
Study site
Essen, 45239
Study site
Heidelberg, 69120
Study site
Herne, 44652
Study site
Hildesheim, 31134
Study site
Osnabrück, 49074
Study site
Ratingen, 40882
Study site
Würzburg, 97080
Spain5 sites
Study site
A Coruña, 15006
Study site
Barcelona, 08036
Study site
Madrid, 28006
Study site
Santiago de Compostela, 15705
Study site
Seville, 41009
Switzerland5 sites
Study site
Aarau, 5000
Study site
Geneva, 1211
Study site
Lausanne, 1011
Study site
Sankt Gallen, 9007
Study site
Zurich, 8091
United Kingdom5 sites
Study site
Cannock, WS11 5XY
Study site
Leeds, LS7 4SA
Study site
London, E11 1NR
Study site
Newcastle upon Tyne, NE1 4LP
Study site
Poole, BH15 2JB
Brazil3 sites
Study site
Curitiba, 80060-240
Study site
Goiânia, 74110010
Study site
São Paulo, 04266-010
Greece3 sites
Study site
Athens, 11527
Study site
Heraklion, 71110
Study site
Thessaloniki, 54642
Mexico3 sites
Study site
Mexicali, 21100
Study site
Mexico City, 11850
Study site
Obregón, 85000
Portugal3 sites
Study site
Almada, 2801-951
Study site
Lisbon, 1649-035
Study site
Porto, 4200-319
Turkey (Türkiye)3 sites
Study site
Ankara, 06100
Study site
Antalya, 07059
Study site
Istanbul, 34098
About this study
Official title: A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab, Adalimumab, Placebo to tocilizumab, Placebo to 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.
TocilizumabDrug
Also called RoActemra, Actemra
The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
AdalimumabDrug
Placebo to tocilizumabDrug
Placebo to adalimumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab 8 mg/kg | Experimental | Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. Receives: Drug: Tocilizumab; Drug: Placebo to adalimumab |
| Adalimumab 40 mg | Active comparator | Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks. Receives: Drug: Adalimumab; Drug: Placebo to tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).
Measured: Baseline to Week 24
Secondary outcomes (5)
Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.
Measured: Week 24
Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24
The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.
Measured: Week 24
Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" [symptom-free and no arthritis symptoms] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
Measured: Baseline to Week 24
Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Measured: Baseline to Week 24
Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
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.
- Publications (4)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 Hoffmann-La RocheThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119859
- Sponsor's protocol ID
- WA19924
- Other IDs
- 2009-015845-21, 2009
- Status last verified
- Jan 2013
- First submitted
- 1 Apr 2010
- Last updated
- 11 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.
PubMed 28955499Gabay C, McInnes IB, Kavanaugh A, Tuckwell K, Klearman M, Pulley J, Sattar N. Comparison of lipid and lipid-associated cardiovascular risk marker changes after treatment with tocilizumab or adalimumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2016 Oct;75(10):1806-12. doi: 10.1136/annrheumdis-2015-207872. Epub 2015 Nov 27.
PubMed 26613768Dennis G Jr, Holweg CT, Kummerfeld SK, Choy DF, Setiadi AF, Hackney JA, Haverty PM, Gilbert H, Lin WY, Diehl L, Fischer S, Song A, Musselman D, Klearman M, Gabay C, Kavanaugh A, Endres J, Fox DA, Martin F, Townsend MJ. Synovial phenotypes in rheumatoid arthritis correlate with response to biologic therapeutics. Arthritis Res Ther. 2014;16(2):R90. doi: 10.1186/ar4555. Epub 2014 Apr 30.
PubMed 25167216Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, Klearman M, Musselman D, Agarwal S, Green J, Kavanaugh A; ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013 May 4;381(9877):1541-50. doi: 10.1016/S0140-6736(13)60250-0. Epub 2013 Mar 18.
PubMed 23515142
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01119859
- Acronym / sponsor ID
- WA19924
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Posted 11 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab 8 mg/kg | Experimental | Drug: Tocilizumab, Drug: Placebo to adalimumabPatients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. |
| Adalimumab 40 mg | Active comparator | Drug: Adalimumab, Drug: Placebo to tocilizumabPatients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients, ≥ 18 years of age.
- Rheumatoid arthritis of > 6 months duration.
- Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
- All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
- Weight ≤ 150 kg.
Key exclusion criteria (5 listed)
- Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
- History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
- Treatment with a biologic agent at any time prior to baseline.
- Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
- Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.
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 |
|---|---|---|
| TocilizumabAlso: RoActemra, ActemraThe maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period. | Drug | Tocilizumab 8 mg/kg |
| Adalimumab | Drug | Adalimumab 40 mg |
| Placebo to tocilizumab | Drug | Adalimumab 40 mg |
| Placebo to adalimumab | Drug | Tocilizumab 8 mg/kg |
Primary outcome
Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
Time frame: Baseline to Week 24
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).
5 secondary outcomes
Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
Time frame: Week 24
Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24
Time frame: Week 24
Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
Time frame: Baseline to Week 24
Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24
Time frame: Baseline to Week 24
Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24
Time frame: Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28955499Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.
- Derived from this study: PubMed 26613768Gabay C, McInnes IB, Kavanaugh A, Tuckwell K, Klearman M, Pulley J, Sattar N. Comparison of lipid and lipid-associated cardiovascular risk marker changes after treatment with tocilizumab or adalimumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2016 Oct;75(10):1806-12. doi: 10.1136/annrheumdis-2015-207872. Epub 2015 Nov 27.
- Derived from this study: PubMed 25167216Dennis G Jr, Holweg CT, Kummerfeld SK, Choy DF, Setiadi AF, Hackney JA, Haverty PM, Gilbert H, Lin WY, Diehl L, Fischer S, Song A, Musselman D, Klearman M, Gabay C, Kavanaugh A, Endres J, Fox DA, Martin F, Townsend MJ. Synovial phenotypes in rheumatoid arthritis correlate with response to biologic therapeutics. Arthritis Res Ther. 2014;16(2):R90. doi: 10.1186/ar4555. Epub 2014 Apr 30.
- Derived from this study: PubMed 23515142Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, Klearman M, Musselman D, Agarwal S, Green J, Kavanaugh A; ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013 May 4;381(9877):1541-50. doi: 10.1016/S0140-6736(13)60250-0. Epub 2013 Mar 18.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Clinical Trials study director
Hoffmann-La Roche
82 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tocilizumab and Adalimumab in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 82 sites in 15 countries.
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 5 inclusion and 5 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Germany, Spain, Switzerland, United Kingdom and 10 more countries. 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 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?
Yes. Results are posted in the registry (first posted 11 Feb 2013). 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 to Week 24 in the Disease Activity Score 28 (DAS28) (time frame: Baseline to Week 24). 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 NCT01119859, which also lists 4 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 11 Feb 2013.