[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

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Study’s contact

Call center

+33144492572

Email address

lbigot@pibd-net.org

Condition

Crohn's Disease

Treatment type

Interventional

Investigational product

Adalimumab

Phase

Phase 4

Sponsor

PIBD-Net

ClinicalTrials.gov identifier

NCT02852694

Study number

201601

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About the study

The purpose of this study is to compare the effectiveness of weekly subcutaneously administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition -free 1-year remission compared with: - daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease - subcutaneously administered adalimumab in high risk paediatric Crohn's disease

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. 120) are possible at inclusion (patients in remission and patients with active
  2. disease) 4. Luminal active Crohn Disease (
  3. B1) with or without B2 and/or B3 disease behavior 5. Initial exposure to 5-ASA and derivate is tolerated 6. Exposure to antibiotics is tolerated 7. If one of the following criteria is present, patients are allocated to the high risk group prior randomization: - Complex fistulizing perianal disease - Panenteric disease phenotype (defined as L3 with L4b per Paris classification or L3 with deep ulcers in duodenum, stomach or oesophagus (not HP (helicobacter pylori)- or NSAID-
  4. related)) - Severe growth impairment (height z-score <-2 or crossing 2 percentiles or
  5. more) likely related to CD - Significant hypoalbuminemia (<30g/l), elevated C reactive protein (
  6. CRP) (at least 2 times above normal range), or wPCDAI >12.5 despite 3 weeks of optimized induction therapy with steroids or Exclusive enteral nutrition - B2, B3 or B2B3 disease behavior - Overall cumulative disease extend of ≥60 cm 8. Informed and signed consent
Exclusion criteria
  1. desease) -related medications other than induction therapy as detailed in this protocol (except 5-ASA). 4. Pregnancy or refusal to use contraceptives during the study period in pubertal patients (both boys and
  2. girls) unless absolute abstinence (no sexual
  3. activity) is confirmed at each study visit. Positive pregnancy testing throughout the study will trigger prompt withdrawal of the patient from the study. 5. Lactating mothers 6. Children with perianal fistulising disease who require surgical therapy (drainage, seton
  4. placement) 7. Patients homozygous for Thiopurine methyl transferase or those with Thiopurine methyl transferase activity <6 nmol/h/ml erythrocytes or <9nmol 6MTG (6 methylthioguanine/g Hb/h), unless they qualify as high risk patients 8. Evidence of un-drained and un-controlled abscess/phlegmon 9. Contraindication to any drugs used in the trial (including intolerance/hypersensitivity or allergy to either study drug (thiopurines, methotrexate or
  5. adalimumab)) 10. Current or previous malignancy 11. Serious comorbidities (such as renal insufficiency, hepatitis, respiratory
  6. insufficiency) interfering with drug therapy or interpretation of outcome parameters or will make it unlikely that the patients will finish the trial. 12. Infection with mycobacterium tuberculosis 13. Moderate to severe heart failure (NYHA classe III/
  7. IV) 14. Oral anticoagulant therapy, anti-malaria therapy 15. Live vaccines exposure (including yellow
  8. fever) less than 3 weeks prior inclusion

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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