ISRCTN70800019CompletedNot Applicable
Observational study on the effects of IL-6 inhibitor therapy on adipokines in patients with rheumatoid arthritis
niversity of Liverpool0 sites19 target enrollmentStarted: April 5, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 19
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or non-pregnant, non-nursing female
- •2. = 18 years of age
- •3. Diagnosis of moderate to severe active RA of = 6 months duration
- •4. DAS28 = 3.2 at screening and baseline
- •5. Receiving treatment on an outpatient basis
- •6. If inadequate response to a biologic DMARD, this treatment was discontinued ?according to approximately 5-half lives for the agent, prior to receiving TCZ. That is, prior to randomization, have discontinued etanercept for = 2 weeks, infliximab or adalimumab for = 8 weeks, anakinra for = 1 week; rituxamab > 24 weeks (or B-cell count has returned to levels prior to treatment and pt meets active disease criteria)
- •7. If continuing a non-biologic DMARD, dose was stable for at least 8 weeks.
- •8. In patients receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment (baseline).
- •9. Able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion Criteria
- •1. Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery
- •2. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty’s syndrome). Patients with interstitial pulmonary disease and still able to tolerate MTX therapy are permitted, as is Sjögren’s Syndrome with RA
- •3. Functional class IV as defined by the ACR Classification of Functional Status in RA (largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care)
- •4. Prior history of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriasic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •Drug-specific:
- •5. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening.
- •6. Previous treatment with any cell-depleting therapies, including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19).
- •7. Treatment with leflunomide in combination with MTX (washout at least 12 weeks, 8 weeks with cholestyramine)
- •8. Treatment with IV gamma globulin, plasmapheresis or Prosorba® column within 6 months before baseline
- •9. Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline
- •10.Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- •11.Previous treatment with TCZ
- •12.Any previous treatment with alkylating agents, such as cyclophosphamide or ?chlorambucil, or with total lymphoid irradiation
- •Laboratory analyses (at screening):
- •13. Serum creatinine > 142 µmol/L (1.6 mg/dL) in female patients and > 168 µmol/L (1.9 mg/dL) in male patients and no active renal disease.
- •14.ALT (SGPT) or AST (SGOT) > 1.5 ULN (If initial sample yields ALT [SGPT] or AST [SGOT] > 1.5 ULN, a second sample may be taken and tested during the screening period)
- •15.Platelet count < 100 x 109/L (100,000/mm3)
- •16.Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
- •17.WBC count < 2.0 x 109/L (2000/mm3), ANC < 1.0 x 109/L (1000/mm3)
- •18.ALC < 0.5 x 109/L (500/mm3)
- •19.Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody
- •20.Total bilirubin > ULN (If initial sample yields bilirubin > ULN, a second sample may ?be taken and tested during the screening period) – unless diagnosis of Gilbert’s ?syndrome
- •21. Triglycerides > 10 mmol/L (> 900 mg/dL) at screening (non-fasted)
- •General medical:
- •22.Pregnant women or nursing (breastfeeding) mothers
- •23.Females of child-bearing potential who were not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD
- •24.History of severe allergic or anaphylactic reactions to human, humanized, or murine ?monoclonal antibodies
- •25.CXR evidence of any clinically significant abnormality, per investigator evaluation
- •26.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease
- •27.In patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment, the treating physician considered the benefit-risk ratio
- •28.A history of chro
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