Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Cannabidiol tablet 10 mg
Pharmaceutical Form: Tablet
CAS Number: 13956-29-1
Other descriptive name: CANNABIDIOL
Pharmaceutical form of the placebo: Tablet
Route of administration of the
Sponsors
King Christian 10th Hospital for Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are patients diagnosed with seropositive RA, more specifically inflammatory well-treated patients, characterized by absence of arthritis at 40 counts and normal C-reactive protein (CRP) or with diagnosis AS in accordance with the modified New York criteria, i.e. based on physiotherapy and / or non-steroidal anti-inflammatory drugs (NSAIDs) and / or bDMARD inflammatory well-treated patients, characterized by absence of axial and peripheral arthritis as well as clinically detectable entesitis, as assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: a. Age 10 mg/L d. Swollen Joints e. Comorbidities, more specific competitive rheumatologic disorders such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma or polymyositis, chronic pain condition based on a further etiology (e.g. fibromyalgia) f. Severe competing cardiovascular, pneumological, neurological, endocrinological, gastro-enterological, urogenital or nephrological disorder g. Major surgery performed <8 weeks before randomization or planned major surgical interventions h. Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids. i. Verified cancer j. Known actual or previous alcohol or drug abuse k. Ongoing treatment with opiods and / or cannabis products and / or neuroleptics, or treatment terminated less than 4 weeks before trial start l. Known hypersensitivity to the study compounds m. Suspected or known schizophrenia or other psychotic illness in the family history or other significant psychiatric disorder in addition to depression associated with underlying condition n. Epilepsy or recurrent seizures o. Use of strong CYP3A4 inducers, e.g. rifampicin, carbamazepine, phenytoin, phenobarbital and perforate St. Johns wort. p. severe hepatic/ renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: A significantly improved pain situation as assessed by the number of AS patients that achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 after 12 and/ or 24 weeks of treatment with CBD or 12 weeks of treatment with CBD followed 12 weeks of treatment with the combination of CBD and THC in an open follow-up. A significantly improved life situation as assessed by the number of patients that achieve a Global VAS 20 after 12 and/ or 24 weeks of treatment with CBD or 12 weeks of treatment with CBD followed by 12 weeks of treatment with a combination of CBD and THC in an open follow-up study. The effect of the intervention on the patients attention and concentration is investigated using cognitive tests (Trail Making Test (TMT) and Digit Symbol Substitution Test (DSST)). Additionally, sleep quality is evaluated with the Pitssburgh Sleep Quality Index.;Primary end point(s): The study investigates the effect of CBD, more specific whether the add-on treatment with CBD results in a significantly improved pain situation as assessed by the number of patients achieving an improvement of pain-VAS with a reduction of ? VAS> 20. Assessment takes place after 12 and 24 weeks of active treatment with CBD. B. If the patient does not experience an acceptable effect of the CBD treatment in the assessment after 12 weeks (as defined by study protocol, i.e. pain VAS reduction > 20), the randomization is terminated and the treatment proceeds by a combination of CBD and THC. THC 2.5 mg daily in week 13 and 14, increasing to 5 mg (2.5 mg x 2 daily) in the following two weeks. If no effect has occurred after week 16, the dose increases in the beginning of the 17th week to the maximum of 7.5 mg THC (2.5 mg x 3 daily) in the 3rd week 2. Thus, the study investigates the effect of the combination of CBD and THC, more specific whether the add-on treatment with CBD for 12 weeks followed by the combined treatment of CBD and THC for another 12 weeks r | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes 1) Outcomes: Clinical measurements, i.e. in RA the Disease Activity Score 28-joints (DAS28-CRP), Health Assessment Questionnaire (HAQ) and in the case of AS the Ankylosing spondylitis disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis (BAS)-scores for disease activity (BASDAI), function (BASFI) and measures (BASMI) are registered . Patient Reported Outcome Measures (PROMs) more specific, visual analogue scales (VAS) for fatigue, patient’s global; the Quality of Life (QoL) - and pain- scores SF-36 and PainDETECT are obtained. Furthermore, the effect of intervention on attention and concentration is investigated using the following cognitive test: Trail Making Test (TMT) and Digit Symbol Substitution Test (DSST). Additionally, sleep quality is evaluated with the Pitssburgh Sleep Quality Index and the expected effect for treatment is measured with Credibility/expectancy Questionnare Devilly and semistructured course interviews. Thus, the study investigates the effect of CBD, more specific whether the add-on treatment with CBD results in a significantly improved fatigue situation and as well more holistic qulaity of life situation as assessed by the number of patients achieving an improvement of fatigue-VAS with a reduction of ? VAS> 20 and an improvement of global-VAS with a reduction of ? VAS> 20. Assessment takes place after 12 and 24 weeks of active treatment with CBD. Furthermore, the study investigates the effect of the combination of CBD and THC, more specific whether the add-on treatment with CBD for 12 weeks followed by the combined treatment of CBD and THC for another 12 weeks results in a significantly improved fatigue situation and as well more holistic qulaity of life situation as assessed by the number of patients achieving an improvement of fatigue-VAS with a reduction of ? VAS> 20 and an improvement of global-VAS with a reduction of ? VAS> 20. 2) Exposures, i.e. current treatments with DMAR | — |
Countries
Denmark
Contacts
Public ContactDepartment of Research
King Christian 10th Hospital for Rheumatic Diseases
Outcome results
None listed