Please assess the completion status of the following clinical trial:

Trial Title: Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~Patients must meet the following criteria for participation in the study.~* Male or female; age \> 18 years.~* American College of Rheumatology (ACR) 1988 revised criteria for rheumatoid arthritis.~* Onset of disease age 16 or older.~* Onset of disease at least 3 months prior to enrollment.~* RA patients ages 18-85 with RA of 3 month duration which in the opinion of the examining rheumatologist is clinically stable and will likely not require adjustment of doses of Disease-modifying antirheumatic drugs (DMARDS), NSAIDS, prednisone, anti-tumor necrosis factor (anti-TNF) alpha therapies for the 16 weeks of the treatment phase of the study.~* Patients must agree to discontinue all herbal remedies as described in this protocol.~* Women of childbearing age will be advised to use effective means of contraception for the treatment phase of the trial and for 90 days thereafter. They must have a negative urine pregnancy test at the randomization visit. (Required by the FDA.)~* Men will be advised to use effective means of contraception for the treatment phase of the trial and for 90 days thereafter. (Required by the FDA.)~* Crohn's Disease Activity Index (CDAI) less than or equal to 30 at the baseline visit.~* Patients with a past history of malignant neoplasm will be eligible if they are 1 or greater years with no recurrence of malignant neoplasm.~Exclusion Criteria:~* Inability to render an informed consent in accordance with institutional guidelines.~* Participation in another clinical research study involving the evaluation of another investigational drug within 90 days of entry into this study.~* RA patients on \>7.5 mg prednisone a day.~* RA patients with intra-articular corticosteroid injections during the previous 30 days.~* Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for the study. Hepatitis B abd/or C patients with inactive disease (as determined by PI) will be enrolled.~* Positive urine pregnancy test~* Age 85 years or greater.~* Use of fish oil within the previous 4 weeks of the baseline visit.~* Therapy consisting of auranofin or cyclophosphamide (all other DMARDs are allowed).~* Previous autologous or heterologous stem cell transplantation.~* Active malignant neoplasm or past treatment for malignant neoplasm 1 year from screening visit.~* Use of oral CII within the past 1 year. (Since oral tolerance is short-lived, we will permit patients in the study who have been off oral CII for \> 1 year)~* Diabetes requiring insulin or on oral medications must be well managed at baseline. Adjustment of insulin or on oral medications will be allowed during the study.~* Serum creatinine 2.0 mcg/dL.~* An 1(II) IFN value \<100% of the PBS IFN value within 1 month or less prior to the baseline and less than 25% reduction in APL A12 + 1(II) IFN from 1(II) IFN concentration.~* CDAI \> 30 at the baseline visit.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- Arm 1 (Type: EXPERIMENTAL): The study will have 3 treatment arms each with 10-12 patients who have demonstrated T cell immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients will be randomized to one of the 2 treatment arms (30 micrograms APL A12 or placebo). Each of the 2 treatments will be given for 16 weeks.~Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate.~Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate.
- Arm 2 (Type: EXPERIMENTAL): The next group will receive a higher dose (50 micrograms) and/or placebo (Block 2).~Intervention: Drug treatment will be stopped or interrupted if indicated and medical care will be given as appropriate.
- Arm 3 (Type: EXPERIMENTAL): Block 3 (Arm 3) will include placebo and both doses of APL/A12 to ensure 10-12 patients are enrolled in each arm ( total of approximately 32 subjects) so we will have 24 subjects who complete the 16 weeks of study treatment. Arms 2 and 3 will run simultaneously.~Intervention: Drug treatment will be stopped or interrupted if indicated.

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

Answer: outcome: complete