Rheumatoid ArthritisPhase 4NCT00209859
Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
A Phase 4 study testing Methotrexate and Intraarticular betamethasone in people with Rheumatoid Arthritis, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
To investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Methotrexate and Intraarticular betamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 1998to Nov 2007
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Synovitis in at least 2 joints.
- Compliance with the ACR criteria for RA.
- Duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration).
- Informed consent.
Who cannot join
- Age less than 18 years or more than 75 years
- Lack of co-operability.
- Previous treatment with DMARD
- Corticosteroid treatment during the preceding 4 weeks.
- Contra indications for the treatments (awaiting the recommendations from Novartis)
- Previous or present malignant or premalignant disease
Show all 23Show fewer
- Poorly regulated hypertension
- Impaired renal function
- Immuno defective diseases, including HIV
- Cardiac or pulmonary insufficiency
- Serious arteriosclerosis
- Serious granulocytopenia or thrombocytopenia
- Impaired liver function (liver enzymes more than twice the highest normal limit).
- Alcohol consumption of more than 3 drinks a week.
- Poorly controlled epilepsy
- Lack of contraception in fertile patients
- Pregnancy and lactation
- Psoriasis
- Poorly regulated diabetes
- Anticoagulant treatment
- Known allergy to the medicine
- Medicamental interactions
- Other inflammatory rheumatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.
To investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis.
Read the detailed description
Design: Multicentre, prospective, randomised, double-blind study with parallel design.
Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent synovitis).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Methotrexate, Intraarticular betamethasone, Cyclosporine/placebo-cyclosporine
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Intraarticular betamethasoneDrug
Cyclosporine/placebo-cyclosporineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 response
Secondary outcomes (4)
ACR remission (modified)
Cumulated dose of glucocorticoids
Development of erosions
Development of osteopenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 1998
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Merete L Hetland, MD, PhD, Principal investigator, Hvidovre Univervsity HospitalKim Hørslev-Petersen, MD, DSc, Principal investigator, Rheumatism Hospital Graasten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209859
- Sponsor's protocol ID
- 232-002
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Publications
Herly M, Stengaard-Pedersen K, Vestergaard P, Ostergaard M, Junker P, Hetland ML, Horslev-Petersen K, Ellingsen T. The D-vitamin metabolite 1,25(OH)2 D in serum is associated with disease activity and Anti-Citrullinated Protein Antibodies in active and treatment naive, early Rheumatoid Arthritis Patients. Scand J Immunol. 2018 Sep;88(3):e12704. doi: 10.1111/sji.12704. Epub 2018 Aug 22.
PubMed 30048002Herly M, Stengaard-Pedersen K, Horslev-Petersen K, Hetland ML, Ostergaard M, Christensen R, Logstrup BB, Vestergaard P, Podenphant J, Junker P, Ellingsen T. Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial: protocol for a cohort study with patient-record evaluated outcomes. BMJ Open. 2017 Apr 8;7(4):e014816. doi: 10.1136/bmjopen-2016-014816.
PubMed 28391237Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1.
PubMed 22302316Christensen AF, Horslev-Petersen K, Christgau S, Lindegaard HM, Lottenburger T, Junker K, Hetland ML, Stengaard-Pedersen K, Jacobsen S, Ellingsen T, Andersen LS, Hansen I, Skjodt H, Pedersen JK, Lauridsen UB, Svendsen AJ, Tarp U, Podenphant J, Heegaard NH, Vestergaard A, Jurik AG, Ostergaard M, Junker P. Uncoupling of collagen II metabolism in newly diagnosed, untreated rheumatoid arthritis is linked to inflammation and antibodies against cyclic citrullinated peptides. J Rheumatol. 2010 Jun;37(6):1113-20. doi: 10.3899/jrheum.091265. Epub 2010 May 1.
PubMed 20436079Christensen AF, Sorensen GL, Horslev-Petersen K, Holmskov U, Lindegaard HM, Junker K, Hetland ML, Stengaard-Pedersen K, Jacobsen S, Lottenburger T, Ellingsen T, Andersen LS, Hansen I, Skjodt H, Pedersen JK, Lauridsen UB, Svendsen A, Tarp U, Podenphant J, Vestergaard A, Jurik AG, Ostergaard M, Junker P. Circulating surfactant protein -D is low and correlates negatively with systemic inflammation in early, untreated rheumatoid arthritis. Arthritis Res Ther. 2010;12(2):R39. doi: 10.1186/ar2948. Epub 2010 Mar 8.
PubMed 20211020Hetland ML, Ejbjerg B, Horslev-Petersen K, Jacobsen S, Vestergaard A, Jurik AG, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Skjodt H, Pedersen JK, Majgaard O, Svendsen AJ, Ellingsen T, Lindegaard H, Christensen AF, Vallo J, Torfing T, Narvestad E, Thomsen HS, Ostergaard M; CIMESTRA study group. MRI bone oedema is the strongest predictor of subsequent radiographic progression in early rheumatoid arthritis. Results from a 2-year randomised controlled trial (CIMESTRA). Ann Rheum Dis. 2009 Mar;68(3):384-90. doi: 10.1136/ard.2008.088245. Epub 2008 Apr 3.
PubMed 18388160
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00209859
- Acronym / sponsor ID
- 232-002
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 1998
- Study completion
- Nov 2007
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis.
Detailed description
Design: Multicentre, prospective, randomised, double-blind study with parallel design.
Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent synovitis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Synovitis in at least 2 joints.
- Compliance with the ACR criteria for RA.
- Duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration).
- Informed consent.
Key exclusion criteria (23 listed)
- Age less than 18 years or more than 75 years
- Lack of co-operability.
- Previous treatment with DMARD
- Corticosteroid treatment during the preceding 4 weeks.
- Contra indications for the treatments (awaiting the recommendations from Novartis)
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 |
|---|---|---|
| Methotrexate | Drug | – |
| Intraarticular betamethasone | Drug | – |
| Cyclosporine/placebo-cyclosporine | Drug | – |
Primary outcome
ACR20 response
4 secondary outcomes
ACR remission (modified)
Cumulated dose of glucocorticoids
Development of erosions
Development of osteopenia
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 21 Sep 2005.
- Derived from this study: PubMed 30048002Herly M, Stengaard-Pedersen K, Vestergaard P, Ostergaard M, Junker P, Hetland ML, Horslev-Petersen K, Ellingsen T. The D-vitamin metabolite 1,25(OH)2 D in serum is associated with disease activity and Anti-Citrullinated Protein Antibodies in active and treatment naive, early Rheumatoid Arthritis Patients. Scand J Immunol. 2018 Sep;88(3):e12704. doi: 10.1111/sji.12704. Epub 2018 Aug 22.
- Derived from this study: PubMed 28391237Herly M, Stengaard-Pedersen K, Horslev-Petersen K, Hetland ML, Ostergaard M, Christensen R, Logstrup BB, Vestergaard P, Podenphant J, Junker P, Ellingsen T. Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial: protocol for a cohort study with patient-record evaluated outcomes. BMJ Open. 2017 Apr 8;7(4):e014816. doi: 10.1136/bmjopen-2016-014816.
- Derived from this study: PubMed 22302316Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1.
- Derived from this study: PubMed 20436079Christensen AF, Horslev-Petersen K, Christgau S, Lindegaard HM, Lottenburger T, Junker K, Hetland ML, Stengaard-Pedersen K, Jacobsen S, Ellingsen T, Andersen LS, Hansen I, Skjodt H, Pedersen JK, Lauridsen UB, Svendsen AJ, Tarp U, Podenphant J, Heegaard NH, Vestergaard A, Jurik AG, Ostergaard M, Junker P. Uncoupling of collagen II metabolism in newly diagnosed, untreated rheumatoid arthritis is linked to inflammation and antibodies against cyclic citrullinated peptides. J Rheumatol. 2010 Jun;37(6):1113-20. doi: 10.3899/jrheum.091265. Epub 2010 May 1.
- Derived from this study: PubMed 20211020Christensen AF, Sorensen GL, Horslev-Petersen K, Holmskov U, Lindegaard HM, Junker K, Hetland ML, Stengaard-Pedersen K, Jacobsen S, Lottenburger T, Ellingsen T, Andersen LS, Hansen I, Skjodt H, Pedersen JK, Lauridsen UB, Svendsen A, Tarp U, Podenphant J, Vestergaard A, Jurik AG, Ostergaard M, Junker P. Circulating surfactant protein -D is low and correlates negatively with systemic inflammation in early, untreated rheumatoid arthritis. Arthritis Res Ther. 2010;12(2):R39. doi: 10.1186/ar2948. Epub 2010 Mar 8.
- Derived from this study: PubMed 18388160Hetland ML, Ejbjerg B, Horslev-Petersen K, Jacobsen S, Vestergaard A, Jurik AG, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Skjodt H, Pedersen JK, Majgaard O, Svendsen AJ, Ellingsen T, Lindegaard H, Christensen AF, Vallo J, Torfing T, Narvestad E, Thomsen HS, Ostergaard M; CIMESTRA study group. MRI bone oedema is the strongest predictor of subsequent radiographic progression in early rheumatoid arthritis. Results from a 2-year randomised controlled trial (CIMESTRA). Ann Rheum Dis. 2009 Mar;68(3):384-90. doi: 10.1136/ard.2008.088245. Epub 2008 Apr 3.
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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.
Merete L Hetland, MD, PhD principal investigator
Hvidovre Univervsity Hospital
Kim Hørslev-Petersen, MD, DSc principal investigator
Rheumatism Hospital Graasten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and Intraarticular betamethasone in people with Rheumatoid Arthritis, run by Hvidovre University Hospital 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 4 inclusion and 23 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 21 Sep 2005. 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. 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?
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?
ACR20 response. 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 NCT00209859, which also lists 6 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 21 Sep 2005.