Arthritis, RheumatoidPhase 3OPERANCT00660647
Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)
A Phase 3 study testing Adalimumab in people with Arthritis, Rheumatoid, run by University of Aarhus at 1 site in Denmark.
Trial summary
Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2007to Dec 2011
- 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
- 1. Patients (more than 18 years) with rheumatoid arthritis according to the ACR classification criteria (1) who have had the diagnose < 6 months.
- 2. Moderate to severe rheumatoid arthritis defined as DAS28 (CRP-based) > 3.2.
- 3. Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. (Non-fertile women are defined as postmenopausal for at least 1 year or surgical sterilisation (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)). Fertile women included in the trial should use contraception during the entire trial period (i.e. one of the following methods: Oral contraception, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). In addition, contraception should be used for a period of 150 days after any discontinuation of trial medicine.
- 4. Ability and willingness to inject the sc. injections him/herself or to have an assistant give the injections.
- 5. Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Who cannot join
- 1. Persons with latent TB defined with a positive Mantoux test (>12 mm for vaccinated and 6 mm for non-vaccinated), positive cultivation of mycobacteria in tissue samples, chest X-ray indicating TB,or other risk factors for activation of untreated latent TB, and persons not been given adequate TB prophylaxis according to the instructions of the department.
- 2. Active or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within the last 30 days or oral antibiotics within the last 14 days prior to inclusion
- 3. Positive serology for Hepatitis B or C indicating active infection.
- 4. Medical history with a positive HIV status (Check of HIV test upon suspicion).
- 5. Medical history with histoplasmosis or listeriosis.
- 6. Previous cancer or lymph proliferative disease except cases teated radically and have been without relapse for a minimum of 5 years.
Show all 19Show fewer
- Patients with previous squamous cell carcinoma, basal cell skin carcinoma or cervical dysplasia, who have been treated successfully and radically can be included.
- 7. Previous diagnosis or signs of demyelinized disease in the CNS system (e.g. optic neuritis, visual disorder, disturbed gait, facial paralysis, apraxia).
- 8. Severe renal insufficiency (creatinine clearance < 35 ml/min - nomogram).
- 9. Affected liver function: Liver enzymes > 2 x above normal limit value.
- 10. Clinical significant drug or alcohol abuse during the past year and/or current daily alcohol consumption.
- 11. Unstable diabetes, unstable ischemic heart disease, heart insufficiency (NYHA III-IV), active chronic inflammatory intestinal disease, recent cerebral apoplexia (within 3 months), chronic leg ulcer or any other condition (e.g. kateter a demeure)which according to the investigator imposes an increased risk to the subject, if he/she participates in the protocol.
- 12. Anticoagulant therapy.
- 13. Pregnancy or breast-feeding.
- 14. Other inflammatory rheumatic diseases.
- 15. Aggressive parvovirus B19 infection.
- 16. Previous treatment with one or more DMARDs.
- 17. Glucocorticosteroid treatment within the last 4 weeks (except nasal and inhalation steroids).
- 18. Contraindications for trial medicine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid Arthritis
Optimized treatment algorithm in early rheumatoid arthritis:
Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis.
A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development.
Optimized Treatment Algorithms for Patients with Early RA
Read the detailed description
In newly diagnosed rheumatoid arthritis patients it is recommended to treat as soon as possible with methotrexate and steroids However, this treatment algorithm, will only bring one third of the patients into remission and cannot stop progressive, persistent joint damage. The possible benefits and risks of adding adalimumab to this conventional treatment algorithm is unknown.
The aim of the study is to clarify the possible benefits of adding adalimumab an anti-TNF-alfa inhibitor versus placebo to the treatment of rheumatoid arthritis patients, who are treated very early and given methotrexate and intraarticular triamcinolone hexacetonide. Efficacy will be evaluated by DAS 28, ACR 20/50/70, HAQ, progressive changes in X-ray, MRI and DXA-scans.
Adverse events will also be registered.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Adalimumab, Placebo
- Keywords
- Rheumatoid arthritis, adalimumab, efficacy, adverse events
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
Adalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years
PlaceboDrug
Also called Saline
Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| methotrexate + adalimumab | Experimental | Methotrexate and intraarticular triamcinolone hexacetonide plus adalimumab. Receives: Drug: Adalimumab |
| methotrexate + placebo | Placebo comparator | Methotrexate and intraarticular triamcinolone hexacetonide and placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who achieve a DAS28 < 3.2
Measured: 0, 1, 3, 6, 9, 12 and 24 months (DAS28)
Secondary outcomes (1)
Changes in DAS28 from start of treatment
Measured: 1, 3, 6, 9, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Meda Pharmaceuticals, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Kristian Stengaard-Pedersen, Professor, Principal investigator, Aarhus University/Aarhus University HospitalKim Hørslev-Petersen, Professor, Principal investigator, King Christian X's Rheumatism Hospital, Graasten, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660647
- Sponsor's protocol ID
- VEK-20070008
- Acronym
- OPERA
- Status last verified
- Nov 2015
- First submitted
- 10 Apr 2008
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Skejoe C, Hansen AS, Stengaard-Pedersen K, Junker P, Hoerslev-Pedersen K, Hetland ML, Oestergaard M, Greisen S, Hvid M, Deleuran M, Deleuran B. T-cell immunoglobulin and mucin domain 3 is upregulated in rheumatoid arthritis, but insufficient in controlling inflammation. Am J Clin Exp Immunol. 2022 Jun 15;11(3):34-44. eCollection 2022.
PubMed 35874466Masic D, Stengaard-Pedersen K, Logstrup BB, Horslev-Petersen K, Hetland ML, Junker P, Ostergaard M, Ammitzboll C, Moller S, Christensen R, Ellingsen T. Similar lipid level changes in early rheumatoid arthritis patients following 1-year treat-to-target strategy with adalimumab plus methotrexate versus placebo plus methotrexate: secondary analyses from the randomised controlled OPERA trial. Rheumatol Int. 2021 Mar;41(3):543-549. doi: 10.1007/s00296-020-04756-5. Epub 2021 Jan 2.
PubMed 33386898Sode J, Krintel SB, Carlsen AL, Hetland ML, Johansen JS, Horslev-Petersen K, Stengaard-Pedersen K, Ellingsen T, Burton M, Junker P, Ostergaard M, Heegaard NHH. Plasma MicroRNA Profiles in Patients with Early Rheumatoid Arthritis Responding to Adalimumab plus Methotrexate vs Methotrexate Alone: A Placebo-controlled Clinical Trial. J Rheumatol. 2018 Jan;45(1):53-61. doi: 10.3899/jrheum.170266. Epub 2017 Nov 15.
PubMed 29142030Glinatsi D, Baker JF, Hetland ML, Horslev-Petersen K, Ejbjerg BJ, Stengaard-Pedersen K, Junker P, Ellingsen T, Lindegaard HM, Hansen I, Lottenburger T, Moller JM, Ornbjerg L, Vestergaard A, Jurik AG, Thomsen HS, Torfing T, Moller-Bisgaard S, Axelsen MB, Ostergaard M. Magnetic resonance imaging assessed inflammation in the wrist is associated with patient-reported physical impairment, global assessment of disease activity and pain in early rheumatoid arthritis: longitudinal results from two randomised controlled trials. Ann Rheum Dis. 2017 Oct;76(10):1707-1715. doi: 10.1136/annrheumdis-2017-211315. Epub 2017 Jun 13.
PubMed 28611080Horslev-Petersen K, Hetland ML, Ornbjerg LM, Junker P, Podenphant J, Ellingsen T, Ahlquist P, Lindegaard H, Linauskas A, Schlemmer A, Dam MY, Hansen I, Lottenburger T, Ammitzboll CG, Jorgensen A, Krintel SB, Raun J, Johansen JS, Ostergaard M, Stengaard-Pedersen K; OPERA Study-Group. Clinical and radiographic outcome of a treat-to-target strategy using methotrexate and intra-articular glucocorticoids with or without adalimumab induction: a 2-year investigator-initiated, double-blinded, randomised, controlled trial (OPERA). Ann Rheum Dis. 2016 Sep;75(9):1645-53. doi: 10.1136/annrheumdis-2015-208166. Epub 2015 Oct 21.
PubMed 26489704Ammitzboll CG, Steffensen R, Bogsted M, Horslev-Petersen K, Hetland ML, Junker P, Johansen JS, Podenphant J, Ostergaard M, Ellingsen T, Stengaard-Pedersen K. CRP genotype and haplotype associations with serum C-reactive protein level and DAS28 in untreated early rheumatoid arthritis patients. Arthritis Res Ther. 2014 Oct 31;16(5):475. doi: 10.1186/s13075-014-0475-3.
PubMed 25359432Laustsen JK, Rasmussen TK, Stengaard-Pedersen K, Horslev-Petersen K, Hetland ML, Ostergaard M, Junker P, Hvid M, Deleuran B. Soluble OX40L is associated with presence of autoantibodies in early rheumatoid arthritis. Arthritis Res Ther. 2014 Oct 30;16(5):474. doi: 10.1186/s13075-014-0474-4.
PubMed 25359291Greisen SR, Schelde KK, Rasmussen TK, Kragstrup TW, Stengaard-Pedersen K, Hetland ML, Horslev-Petersen K, Junker P, Ostergaard M, Deleuran B, Hvid M. CXCL13 predicts disease activity in early rheumatoid arthritis and could be an indicator of the therapeutic 'window of opportunity'. Arthritis Res Ther. 2014 Sep 24;16(5):434. doi: 10.1186/s13075-014-0434-z.
PubMed 25249397Ammitzboll CG, Thiel S, Jensenius JC, Ellingsen T, Horslev-Petersen K, Hetland ML, Junker P, Krogh NS, Ostergaard M, Stengaard-Pedersen K. M-ficolin levels reflect disease activity and predict remission in early rheumatoid arthritis. Arthritis Rheum. 2013 Dec;65(12):3045-50. doi: 10.1002/art.38179.
PubMed 24022747
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00660647
- Acronym / sponsor ID
- OPERA / VEK-20070008
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid arthritis, adalimumab, efficacy, adverse events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Abbott, Meda Pharmaceuticals, Aarhus University Hospital
- Study start
- Sep 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 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.
Optimized treatment algorithm in early rheumatoid arthritis:
Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis.
A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development.
Optimized Treatment Algorithms for Patients with Early RA
Detailed description
In newly diagnosed rheumatoid arthritis patients it is recommended to treat as soon as possible with methotrexate and steroids However, this treatment algorithm, will only bring one third of the patients into remission and cannot stop progressive, persistent joint damage. The possible benefits and risks of adding adalimumab to this conventional treatment algorithm is unknown.
The aim of the study is to clarify the possible benefits of adding adalimumab an anti-TNF-alfa inhibitor versus placebo to the treatment of rheumatoid arthritis patients, who are treated very early and given methotrexate and intraarticular triamcinolone hexacetonide. Efficacy will be evaluated by DAS 28, ACR 20/50/70, HAQ, progressive changes in X-ray, MRI and DXA-scans.
Adverse events will also be registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methotrexate + adalimumab | Experimental | Drug: AdalimumabMethotrexate and intraarticular triamcinolone hexacetonide plus adalimumab. |
| methotrexate + placebo | Placebo comparator | Drug: PlaceboMethotrexate and intraarticular triamcinolone hexacetonide and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Patients (more than 18 years) with rheumatoid arthritis according to the ACR classification criteria (1) who have had the diagnose < 6 months.
- 2. Moderate to severe rheumatoid arthritis defined as DAS28 (CRP-based) > 3.2.
- 3. Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. (Non-fertile women are defined as postmenopausal for at least 1 year or surgical sterilisation (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)). Fertile women included in the trial should use contraception during the entire trial period (i.e. one of the following methods: Oral contraception, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). In addition, contraception should be used for a period of 150 days after any discontinuation of trial medicine.
- 4. Ability and willingness to inject the sc. injections him/herself or to have an assistant give the injections.
- 5. Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Key exclusion criteria (19 listed)
- 1. Persons with latent TB defined with a positive Mantoux test (>12 mm for vaccinated and 6 mm for non-vaccinated), positive cultivation of mycobacteria in tissue samples, chest X-ray indicating TB,or other risk factors for activation of untreated latent TB, and persons not been given adequate TB prophylaxis according to the instructions of the department.
- 2. Active or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within the last 30 days or oral antibiotics within the last 14 days prior to inclusion
- 3. Positive serology for Hepatitis B or C indicating active infection.
- 4. Medical history with a positive HIV status (Check of HIV test upon suspicion).
- 5. Medical history with histoplasmosis or listeriosis.
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: HumiraAdalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years | Drug | methotrexate + adalimumab |
| PlaceboAlso: SalineSaline injection 0.9%, 0.8 ml s.c. every second week up to 2 years | Drug | methotrexate + placebo |
Primary outcome
Number of patients who achieve a DAS28 < 3.2
Time frame: 0, 1, 3, 6, 9, 12 and 24 months (DAS28)
1 secondary outcome
Changes in DAS28 from start of treatment
Time frame: 1, 3, 6, 9, 12 and 24 months
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 24 Nov 2015.
- Derived from this study: PubMed 35874466Skejoe C, Hansen AS, Stengaard-Pedersen K, Junker P, Hoerslev-Pedersen K, Hetland ML, Oestergaard M, Greisen S, Hvid M, Deleuran M, Deleuran B. T-cell immunoglobulin and mucin domain 3 is upregulated in rheumatoid arthritis, but insufficient in controlling inflammation. Am J Clin Exp Immunol. 2022 Jun 15;11(3):34-44. eCollection 2022.
- Derived from this study: PubMed 33386898Masic D, Stengaard-Pedersen K, Logstrup BB, Horslev-Petersen K, Hetland ML, Junker P, Ostergaard M, Ammitzboll C, Moller S, Christensen R, Ellingsen T. Similar lipid level changes in early rheumatoid arthritis patients following 1-year treat-to-target strategy with adalimumab plus methotrexate versus placebo plus methotrexate: secondary analyses from the randomised controlled OPERA trial. Rheumatol Int. 2021 Mar;41(3):543-549. doi: 10.1007/s00296-020-04756-5. Epub 2021 Jan 2.
- Derived from this study: PubMed 29142030Sode J, Krintel SB, Carlsen AL, Hetland ML, Johansen JS, Horslev-Petersen K, Stengaard-Pedersen K, Ellingsen T, Burton M, Junker P, Ostergaard M, Heegaard NHH. Plasma MicroRNA Profiles in Patients with Early Rheumatoid Arthritis Responding to Adalimumab plus Methotrexate vs Methotrexate Alone: A Placebo-controlled Clinical Trial. J Rheumatol. 2018 Jan;45(1):53-61. doi: 10.3899/jrheum.170266. Epub 2017 Nov 15.
- Derived from this study: PubMed 28611080Glinatsi D, Baker JF, Hetland ML, Horslev-Petersen K, Ejbjerg BJ, Stengaard-Pedersen K, Junker P, Ellingsen T, Lindegaard HM, Hansen I, Lottenburger T, Moller JM, Ornbjerg L, Vestergaard A, Jurik AG, Thomsen HS, Torfing T, Moller-Bisgaard S, Axelsen MB, Ostergaard M. Magnetic resonance imaging assessed inflammation in the wrist is associated with patient-reported physical impairment, global assessment of disease activity and pain in early rheumatoid arthritis: longitudinal results from two randomised controlled trials. Ann Rheum Dis. 2017 Oct;76(10):1707-1715. doi: 10.1136/annrheumdis-2017-211315. Epub 2017 Jun 13.
- Derived from this study: PubMed 26489704Horslev-Petersen K, Hetland ML, Ornbjerg LM, Junker P, Podenphant J, Ellingsen T, Ahlquist P, Lindegaard H, Linauskas A, Schlemmer A, Dam MY, Hansen I, Lottenburger T, Ammitzboll CG, Jorgensen A, Krintel SB, Raun J, Johansen JS, Ostergaard M, Stengaard-Pedersen K; OPERA Study-Group. Clinical and radiographic outcome of a treat-to-target strategy using methotrexate and intra-articular glucocorticoids with or without adalimumab induction: a 2-year investigator-initiated, double-blinded, randomised, controlled trial (OPERA). Ann Rheum Dis. 2016 Sep;75(9):1645-53. doi: 10.1136/annrheumdis-2015-208166. Epub 2015 Oct 21.
- Derived from this study: PubMed 25359432Ammitzboll CG, Steffensen R, Bogsted M, Horslev-Petersen K, Hetland ML, Junker P, Johansen JS, Podenphant J, Ostergaard M, Ellingsen T, Stengaard-Pedersen K. CRP genotype and haplotype associations with serum C-reactive protein level and DAS28 in untreated early rheumatoid arthritis patients. Arthritis Res Ther. 2014 Oct 31;16(5):475. doi: 10.1186/s13075-014-0475-3.
- Derived from this study: PubMed 25359291Laustsen JK, Rasmussen TK, Stengaard-Pedersen K, Horslev-Petersen K, Hetland ML, Ostergaard M, Junker P, Hvid M, Deleuran B. Soluble OX40L is associated with presence of autoantibodies in early rheumatoid arthritis. Arthritis Res Ther. 2014 Oct 30;16(5):474. doi: 10.1186/s13075-014-0474-4.
- Derived from this study: PubMed 25249397Greisen SR, Schelde KK, Rasmussen TK, Kragstrup TW, Stengaard-Pedersen K, Hetland ML, Horslev-Petersen K, Junker P, Ostergaard M, Deleuran B, Hvid M. CXCL13 predicts disease activity in early rheumatoid arthritis and could be an indicator of the therapeutic 'window of opportunity'. Arthritis Res Ther. 2014 Sep 24;16(5):434. doi: 10.1186/s13075-014-0434-z.
- Derived from this study: PubMed 24022747Ammitzboll CG, Thiel S, Jensenius JC, Ellingsen T, Horslev-Petersen K, Hetland ML, Junker P, Krogh NS, Ostergaard M, Stengaard-Pedersen K. M-ficolin levels reflect disease activity and predict remission in early rheumatoid arthritis. Arthritis Rheum. 2013 Dec;65(12):3045-50. doi: 10.1002/art.38179.
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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.
Kristian Stengaard-Pedersen, Professor principal investigator
Aarhus University/Aarhus University Hospital
Kim Hørslev-Petersen, Professor principal investigator
King Christian X's Rheumatism Hospital, Graasten, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab in people with Arthritis, Rheumatoid, run by University of Aarhus at 1 site in Denmark.
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 19 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 24 Nov 2015. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Number of patients who achieve a DAS28 < 3.2 (time frame: 0, 1, 3, 6, 9, 12 and 24 months (DAS28)). 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 NCT00660647, which also lists 9 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 24 Nov 2015.