Can-ArtEffect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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 < 2.1) and where normally CRP is documented.

Participant with the above mentioned diagnoses and relevant clinical status quo, followed regularly at one of the four departments are invited to participate in the study. Furthermore:

a.Receiving treatment on an outpatient basis
b.Diagnosed for at least 2 years
c.seropositive (anti CCP and/ or IgM RF) RA, radiology (MRI and/ or conventional X-ray) verified AS
d.RA: a stable inflammatory treatment situation achieved by ongoing cDMARD and / or bDMARD, 40 joint count without joint swelling
e.AS: a stable inflammatory treatment situation achieved by ongoing physiotherapy, NSAID, cDMARD and / or bDMARD: ASDAS < 2.1 for at least 4 weeks
f.Ongoing or earlier attempt of treatment with Paracetamol or NSAIDs with the outcome of parameters as mentioned in item e. or f.
g.Pain relief treatment unchanged at least 4 weeks before trial start
h.Minimum Pain VAS 50

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

a.Age < 18 years
b.Pregnancy or desiring pregnancy, ongoing breastfeeding
c.CRP > 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