|- candidate number||24072|
|- NTR Number||NTR5770|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-mrt-2016|
|- Secondary IDs||NL52376.058.15 METC LUMC|
|- Public Title||Conditioning and Health Training in Rheumatoid Arthritis|
|- Scientific Title||The Role of Conditioning and Health Training for Pharmacotherapeutic Treatments in Rheumatoid Arthritis|
|- ACRONYM||EXPECT HEALTH|
|- hypothesis||The aim of the study is to enhance pharmacotherapeutic effects in patients with recent-onset rheumatoid arthritis by means of pharmacological conditioning with or without an online guided health training. It is expected that the interventions will lead to enhanced pharmacotherapeutic effects, as expressed in a larger percentage of patients in drug-free clinical remission (primary hypothesis), as compared to standard treatment.|
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis, Pharmacology, Conditioning|
|- Inclusion criteria||1. Adult (minimum age of 18 years)|
2. Recent-onset rheumatoid arthritis according to the revised American College of Rheumatology (ACR) criteria
3. Fluent in Dutch
4. Able to give informed consent
5. Clinical remission at month 5 after completing the protocolized pharmacological treatment.
|- 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 is 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. Bone marrow hypoplasia.
5. Elevated hepatic enzyme levels (aspartate transaminase [ASAT], alanine transaminase [ALAT] > 3 times normal value).
6. Serum creatinine levels > 150 umol/l or estimated creatinine clearance of < 75%.
7. Uncontrolled diabetes mellitus (according to the rheumatologist).
8. Uncontrolled hypertension (according to the rheumatologist).
9. Alcohol or drug abuse.
10. History of infected joint prosthesis within the previous 3 months.
11. Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months.
12. Chronic infectious disease such as chronic renal infection, chronic chest infection with
a. bronchiectasis or sinusitis.
13. History of opportunistic infections such as herpes zoster within previous 2 months.
14. Not being in the possession of a computer and/or not having access to the internet.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-mrt-2016|
|- planned closingdate||7-mrt-2019|
|- Target number of participants||141|
|- Interventions||current pharmacological treatment recommendations. The study is divided into four periods of four months, with all groups receiving the same cumulative amount of active medication during each period:|
1. Month 1-4: After initial screening, patients who are eligible for stable standard pharmacological treatment will start on MTX and prednisone.
2. Month 5-8: Only patients who completed the baseline period without protocol violations and achieved clinical remission (DAS < 1.6) will continue to the second phase of the study and will be randomized to one of three groups. The different groups will follow different treatment schedules:
a. Control group: standardized treatment dosage (240 mg MTX in total) without health training.
b. Conditioning group: variable treatment dosage of MTX (240 mg MTX in total), without health training.
c. Conditioning with Health Training group: same pharmacological schedule as the Conditioning group (240 mg MTX in total) combined with a health training. Patients will be blind to the pharmacological treatment schedule.
3. Month 9-12: During the third period, MTX will be tapered and discontinued if patients are still in clinical remission (DAS<1.6), with dosages either decreasing linearly (Control group) or variably (Conditioning group and Conditioning with Health Training group), with the same total dosage in all groups.
4. Month 16: End-of-study visit.
Patients will visit the treating hospital for five appointments over a period of 16 months (at
screening and after each period, T1-T5, see Figure 1), coinciding with patientsí regular appointment as much as possible.
|- Primary outcome||The main study endpoint is the difference in the percentage of patients who achieve a drug-free
clinical remission (Disease Activity Score DAS < 1.6) between the combined intervention
groups (Conditioning group and Conditioning with Health Training group) and the
Control group following the tapering period (12 months after the start the of the treatment).
|- Secondary outcome||Secondary study parameters are percentage of clinical remission at 8,12, and 16 months after the start of the treatment, disease activity, cytokine parameters, and other psychological outcome measures assessed at each measuring point. |
|- Timepoints||The study is divided into four periods of four months (16 months in total), with measuring points at the beginning and end of each four-month period, thus comprising 5 assessment points in total (at baseline and 4, 8, 12, and 16 months after start of treatment).|
|- Trial web site||n/a|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. A.W.M. Evers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A.W.M. Evers|
|- Sponsor/Initiator ||Leiden University|
(Source(s) of Monetary or Material Support)
|European Research Council Consolidator Grant|
|- Brief summary||The main aim of this study is to evaluate a conditioning procedure with or without the combination of an online guided health training, aimed at optimizing pharmacological treatment effects. Patients, researchers and clinicians will be blind as to when a high dose is given and when a low dose is given. Patients in the combined experimental group will additionally receive an online guided health training, based on cognitive behavioral therapy principles. The intervention groups will be compared to a standard-treatment control group. Effects on percentage of drug-free clinical remission and other psychophysiological and psychological outcome measures will be examined at 8, 12, and 16 months after the start of treatment. |
|- Main changes (audit trail)|
|- RECORD||3-mrt-2016 - 25-mei-2016|