Conditioning and Health Training in Rheumatoid Arthritis

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.

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.

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).

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 patients’ regular appointment as much as possible.