Please assess the completion status of the following clinical trial:

Trial Title: Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Crohn's disease~2. Age 6-17 (inclusive)~3. Naïve to biologics~4. Informed consent~5. Neg. TB-Test, negative HBV- S Ag~6. Negative stool culture, parasites and clostridium toxin~Inclusion criteria Comments:~1. Patients receiving corticosteroids may be included if on taper-down scheduled to be completed by week 10.~2. Partial enteral nutrition, accounting for less than 50% of daily required calories, may be supplied as needed.~3. Patients receiving antibiotics must cease use of antibiotics within the 14 days of receiving the first injection. Excluding immunomodulators (azathioprine/6MP and methotrexate), any other targeted therapy for crohn's disease (i.e 5-ASA) must be stopped prior to ADA first injection. Immunomodulators will be required to be stopped either prior to first ADA injection or at 6 months following ADA initiation.~Exclusion Criteria:~1. Pregnancy.~2. Renal Failure.~3. Current abscess or perforation of the bowel.~4. Small bowel obstruction within the last 6 months.~5. Fixed non inflammatory stricture with related symptoms.~6. Complicated or heavily draining perianal fistula (indolent non draining or minimally draining fistula are not an exclusion criteria).~7. Prior treatment with infliximab or adalimumab.~8. Previous malignancy.~9. Sepsis or active bacterial infection.~10. Surgery related to Crohn's disease in the previous 8 weeks.~11. Positive Hepatitis B surface antigen or evidence for TB.~12. IBD unclassified.

- Gender: ALL
- Minimum Age: 6 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Interventional (Type: EXPERIMENTAL): Adalimumab levels and antibodies will be obtained with every laboratory examination (every 2 months, except for the first 2 visits). Dose or interval adjustment will be performed as followed:when trough levels results taken prior to ADA injection are above 5 µg/ml no change in dosing is required. Detectable levels below 5 µg/ml will result in interval decrease to every week. If levels are still below 5 µg/ml dose will be increased to 40 mg (in patients receiving less than 40 mg). Undetectable levels below 0.3µg/ml will be followed by antibodies (ATAs) measurement. If ATAs are persistently above 8 µg/ml the patient will discontinue the study. If ATAs are below 8 µg/ml ADA intervals will be decreased to every week.
- Clinical (Type: NO_INTERVENTION): Adalimumab levels and antibodies will be requested based on physician judgment when there are signs of loss of response (LOR). Dose and interval adjustment will be performed according to clinical measures: Following physician decision trough levels and ATAs will be collected and further adjustment may be considered according to results. Interval adjustment will be performed as described for the interventional arm.~LOR is defined as PCDAI equal or higher than 10 or CRP higher than 0.5 mg/dl (5mg/l) and/or Fecal calprotectin higher than 150 mcg/gr (If lower than 150 at randomization).

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete