Clinical trial NCT01264211 (phase 2, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: diacerein, placebo
SMILES: CC(=O)OC1=CC=CC2=C1C(=O)C1=C(OC(C)=O)C=C(C=C1C2=O)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged between 18 and 65 years;

          2. Active RA of ≥ 3 months duration but < 2 years, diagnosed according to the American
             College of Rheumatology (ACR) 1987 revised criteria for RA;

          3. RA global functional status class I-III;

          4. Treatment on an outpatient basis;

          5. Treatment with MTX for a minimum of 12 weeks, with stable weekly dose (10-20 mg) for
             at least 4 weeks before randomisation;

          6. Insufficient response to treatment with MTX, with disease activity score DAS28 > 4.0
             at the time of screening and randomisation; the DAS28 must not change significantly
             from screening to baseline visit (change < 0.6);

          7. Tender joint count (TJC) ≥ 6 (68 joint count) and swollen joint count (SJC) ≥ 6 (66
             joint count) at screening and randomisation;

          8. Screening ESR ≥ 28 mm/h;

          9. Evidence of adequate contraceptive methods in women of childbearing potential. Female
             patients of childbearing potential are those who are not surgically sterile or
             post-menopausal. Adequate contraceptive methods are hormonal contraceptive,
             intra-uterine device, diaphragm with spermicide or condom with spermicide for the
             entire duration of the study;

         10. Agreement not to drink alcohol for the duration of the study;

         11. Ability and agreement to comply with the requirements of the study protocol;

         12. Having given written informed consent to participate in the study.

        Exclusion Criteria:

          1. History of active inflammatory arthritis other than RA;

          2. Any uncontrolled medical condition such as diabetes mellitus, asthma, cardiopulmonary
             disease, congestive heart failure, neurological disease, etc.;

          3. Alcohol abuse, defined as the consumption of more than one glass of beer or wine in a
             day;

          4. Moderate or severe liver disease (cirrhosis, hepatitis, liver insufficiency);

          5. Blood anomalies (significant cytopenia);

          6. History of, or currently active primary or secondary immunodeficiency;

          7. Chronic hepatitis B (HBsAg positive or HBcAb positive with HBV DNA load ≥ 400
             copies/ml) or hepatitis C (anti-HCV positive);

          8. Current known active, or history of, recurrent bacterial, viral, fungal, mycobacterial
             or other infections, or any infection requiring hospitalisation or treatment with i.v.
             antibiotics within 4 weeks prior to randomisation or oral antibiotics within 2 weeks
             prior to randomisation;

          9. Treatment with biologic DMARDs such as TNF antagonists, IL 1 receptor antagonists, IL
             6 receptor antagonists, CTLA4Ig within 12 weeks prior to randomisation, and rituximab
             within 24 weeks prior to randomisation;

         10. Treatment with non-biologic DMARDs such as chloroquine, hydroxychloroquine,
             penicillamine, sulfasalazine within 4 weeks prior to randomisation, leflunomide,
             parenteral gold, oral gold within 8 weeks prior to randomisation, azathioprine and
             ciclosporin within 12 weeks prior to randomisation;

         11. Treatment with intra-articular injection of a depocorticosteroid within 8 weeks prior
             to randomisation;

         12. Treatment with NSAID or oral corticosteroids, unless the patient has been on a stable
             dose for at least 4 weeks before randomisation (maximal allowed daily dose of oral
             corticosteroid equivalent to prednisone 10 mg);

         13. Physical therapy and alternative therapies, unless the patient has received them
             regularly for at least 4 weeks before randomisation;

         14. Initiation of chronic treatment with antihistaminics, antidepressants or
             tranquilisers, within less than 12 weeks before randomisation.