[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

Email address

Emberly.Dumayas@grifols.com

Condition

Pulmonary Emphysema in Alpha-1 PI Deficiency

Treatment type

Interventional

Investigational product

Alpha-1 MP

Phase

Phase 3

Sponsor

Grifols Therapeutics LLC

ClinicalTrials.gov identifier

NCT01983241

Study number

GTi1201

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About the study

This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of a Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.

Who can take part?

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

Inclusion criteria
  1. Have a documented total alpha1-PI serum level < 11 µM.
  2. Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or "at-risk" alleles.
  3. At the Screening (Week -3) Visit, have a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and < 80% of predicted and FEV1/forced vital capacity (FVC) < 70% (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II or III).
  4. Have a carbon monoxide diffusing capacity (DLCO) ≤ 60% of predicted (corrected for HgB) within the past 2 years OR evidence of pulmonary emphysema on CT scan within the past 2 years per the Investigator's judgment.
  5. Have clinical evidence of pulmonary emphysema per the Investigator's judgment.
Exclusion criteria
  1. Has received alpha1-PI augmentation therapy for more than 1 month within the six months prior to the Screening Visit.
  2. Has received alpha1-PI augmentation therapy within one month of the Screening Visit.
  3. Has had a chronic obstructive pulmonary disease (COPD) exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase.
  4. Unable to physically (e.g., unable to fit inside the CT scanner) or mentally (e.g., claustrophobic) undergo a CT scan.
  5. History of lung or liver transplant.
  6. Any lung surgery during the past 2 years (excluding lung biopsy).
  7. On the waiting list for lung surgery, including lung transplant.
  8. Smoking during the past 12 months or a positive urine cotinine test at screening that is due to smoking. Maybe on Nicotine replacement, including vapor cigarettes.
  9. History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
  10. Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e., 10 mg every 2 days) within the 5 weeks prior to the Screening Visit (inhaled steroids are not considered systemic steroids) or during the Screening Phase.
  11. Use of systemic or aerosolized antibiotics for a COPD exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase.
  12. Known selective or severe Immunoglobulin A (IgA) deficiency.

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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