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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR801 |
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Date of registration:
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07/11/2006 |
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Primary sponsor: |
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Public title:
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IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic Disease.
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Scientific title:
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A randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent. - IMPROVED |
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Date of first enrolment:
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1/1/2007 |
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Target sample size:
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610 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=801 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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C.F.
Allaart |
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Address:
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Leiden University Medical Center (LUMC),
Department of Rheumatology,
C1-39,
P.O. Box 9600
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5263598 |
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Email:
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c.f.allaart@lumc.nl |
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Affiliation:
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Name:
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K.
Boer, de |
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Address:
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P.O. Box 9600, Leiden University Medical Center, Department of Rheumatology, C4-R
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5261280 |
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Email:
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K.V.C.de_boer@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients >=18 years of age with either RA according to the revised criteria of the American College of Rheumatology (ACR) (29) of less than two years duration, or UA, suspected by the rheumatologist to have an early presentation of RA;
2. All patients must have at least one (out of 66) swollen joint and at least one other (out of 68) painful joint, and a combined DAS of >1.6;
3. All patients must be DMARD- and corticosteroid naïve.
Exclusion criteria: 1. Previous therapy with DMARDs or with corticosteroids (exception: one dose of parenteral corticosteroids within the last 6 months, but not within the last 2 months, or an oral dose of prednisone of =<10 mg/day for =< 2 weeks within the same period allowed);
2. Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception;
3. Concomitant treatment with another experimental drug;
4. History or presence of malignancy within the last five years;
5. Bone marrow hypoplasia;
6. Elevated hepatic enzyme levels (ASAT, ALAT > 3 times normal value);
7. Serum creatinine level > 150 umol/l or estimated creatinin clearance of < 75%;
8. Uncontrolled diabetes mellitus (according to the rheumatologist);
9. Uncontrolled hypertension (according to the rheumatologist);
10. Heart failure (NYHA functional class III or IV);
11. Alcohol or drug abuse;
12. History of infected joint prothesis within the previous 3 months;
13. Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months;
14. Chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis;
15. History of active tuberculosis requiring treatment within previous 3 years, or signs and symptoms of latent infection with tuberculosis, based on medical history, physical examination, PPD skin test, X-thorax;
16. History of opportunistic infections such as herpes zoster within previous 2 months;
17. Evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium infection etc;
18. Evidence of hepatitis B infection;
19. Documented HIV infection, AIDS related complex (ARC) or AIDS;
20. History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease;
21. Multiple sclerosis or neurological symptoms suspect for demyelinizing disease.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis, Undifferentiated arthritis
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Intervention(s)
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Four-monthly evaluations of disease activity score and safety. Medication adjustments by protocol, based on DAS calculation, aimed at DAS <1.6 (remission). Initial treatment with methotrexate and a tapered high dose of prednisone. If DAS >1.6, randomisation to either combination with MTX, SSA, hydroxychloroquine and a tapered high dose of prednisone, or combination with MTX with adalimumab. In case of DAS <1.6: taper medication and discontinue if DAS remains <1.6.
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Primary Outcome(s)
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Percentage of patients in remission (DAS <1.6), functional ability as measured by HAQ, radiological damage progression as measured by Sharp/van der Heijde score.
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Secondary Outcome(s)
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Quality of life, as measured with MACTAR, SF-36, EuroQol, Time-trade-off. Costs. ACR arthritis core-set.
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Secondary ID(s)
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ISRCTN11916566
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Source(s) of Monetary Support
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Abbott
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