[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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Condition

Osteoarthritis of the Knee

Treatment type

Interventional

Investigational product

X0002

Phase

Phase 3

Sponsor

Techfields Pharma Co. Ltd

ClinicalTrials.gov identifier

NCT03081806

Study number

TF-X0002-31

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About the study

This is a Phase 3, Multicenter, 22-Week, double-blind and 30-Week open label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of subjects with Osteoarthritis of the Knee.

Who can take part?

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

Inclusion criteria
  1. BMI) between 18.5 and 40 kg/m2, inclusive. 6. Subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology clinical and radiographic criteria with knee pain, osteophytes, and fulfillment of at least one of the 3 criteria: - age of ≥50 years - stiffness lasting <30 minutes after getting up in the morning - crepitus 7. A subject must have a Kellgren Lawrence Grade of 2 or 3 as determined by a central radiologist at the first screening visit. 8. Subject must have a history of clinically symptomatic OA of the knee for ≥6 months. 9. Subject must have had knee pain while standing, walking, and/or in motion for at least 14 days during the month prior to Screening. 10. Subject must have a knee pain score ≥4 and <9 on 0-10 pain intensity NRS (without analgesic
  2. medication) on at least 7 of the 10 days prior to randomization. 11. Subject must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin,
  3. acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy,
  4. acupuncture) starting on the first screening visit until completing participation in the study. (The use of ≤325 mg acetylsalicylic acid per day as cardiac prophylaxis is permitted.) The subject will be allowed to take rescue medication (
  5. acetaminophen) for pain during the study except during the 24 hours prior to the Second Screening Visit, Baseline (Day1), Week 2, Week 4, Week 8, Week 12, Week 22, Week 32, Week 42, and Week 52/EOS. 12. Subject must be willing to discontinue applying any topical preparations containing Vitamin A acids (including all trans retinoic acid (tretinoin), 13 cis retinoic acid [isotretinoin], 9 cis retinoic acid [alitretinoin], vitamin A [retinol], retinal, and their
  6. derivatives) to the lower limbs starting on the first screening visit until completing participation in the study. (Topical preparations containing Vitamin A acids or retinol may be applied to areas of the skin above the waist, but should not be applied to areas of the skin exposed to study medication.) 13. Subject must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting
  7. routine) for the duration of the study starting on the first screening visit. 14. With the exception of OA of the knee, the subject must be in good general health with no clinically significant findings from medical history, vital signs, physical examination, ECG, and routine laboratory tests that could interfere with subject safety, or pain and functional assessments, as determined by the Investigator.
Exclusion criteria
  1. 1) that, in the investigator's opinion, would affect absorption of the medication. 7. Has used opiates (including tramadol or
  2. tapentadol) or systemic corticosteroids within 30 days before Screening or requires treatment with chronic opiates or systemic corticosteroids. 8. Subjects with a placebo response exceeding 25% improvement in the average Western Ontario and McMaster Osteoarthritis Index [WOMAC] pain subscale score from Screening Visit to Day 1 will be excluded. 9. Has used gabapentin, pregabalin, antiepileptics, or specific antidepressants (i.e., tricyclics, serotonin norepinephrine reuptake inhibitors, or selective serotonin reuptake
  3. inhibitors) to treat pain in the 14 days before Screening. Other uses not related to the pain treatment may be permitted at the medical monitor's discretion provided they have been at a stable dose for at least 90 days. 10. Has had intra articular (
  4. IA) injections of corticosteroids, hyaluronic acid, or viscosupplements (e.g., Synvisc®) to the target knee within the 12 weeks before Screening 11. Has had IA or intravenous (
  5. IV) stem cell therapy in the 6 months prior to Screening 12. Is receiving or is planning to receive concomitant nonpharmacologic treatments (e.g., physiotherapy,
  6. acupuncture) that in the investigator's opinion could confound efficacy assessments within 14 days of Day 1. 13. Has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen or any other NSAIDs, aspirin, or acetaminophen. 14. Has had an active gastrointestinal (
  7. GI) ulceration in the 6 months prior to Screening or a history of GI bleeding within 5 years of Screening. 15. Has used an anticoagulant or antiplatelet agent (except aspirin up to 325 mg/day for cardiac
  8. prophylaxis) in the 30 days prior to Screening. 16. Has positive results on fecal occult blood testing at Screening or on Day 1. 17. Has a documented history of chronic inflammatory disease (e.g., rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, gouty
  9. arthritis) OR chronic pain condition (e.g., fibromyalgia), OR has other conditions that may affect the target joint for the functional and pain assessments (e.g., osteonecrosis, chondrocalcinosis). 18. Has uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder, if using medication, must be on a stable dose of a medication other than an epileptic, tricyclic, serotonin norepinephrine reuptake inhibitor, or selective reuptake inhibitor for ≥12 weeks prior to Screening to participate in the study). 19. Has asthma requiring treatment with systemic corticosteroids in the last year prior to Screening. Asthmatic subjects using inhaled corticosteroids are eligible. 20. Has uncontrolled hypertension defined as systolic blood pressure >170 mmHg or diastolic blood pressure >90 mmHg at the Screening or Baseline Visit (may be repeated after 5 minutes rest to verify). 21. Is receiving systemic chemotherapy, has an active malignancy, lymphoproliferative disorder, or blood dyscrasia of any type, or has been diagnosed with cancer within 5 years before Screening. Subjects with completely excised squamous or basal cell carcinoma of the skin will be allowed. 22. Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, hepatic, or renal disease, or any other condition that, in the Investigator's opinion, could confound the study results, compromise the subject's welfare, interfere with the ability to communicate with the study staff, or otherwise contraindicate study participation. 23. Has an abnormal clinical laboratory assessment at Screening for any of the following: - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase or lactate dehydrogenase (
  10. LDH) ≥3× the upper limit of normal (
  11. ULN) - Total bilirubin or creatinine ≥1.5× ULN - Creatinine ≥1.5 × ULN - Hemoglobin <10 g/dL 24. Subject has any other clinically significant laboratory finding at Screening that in the investigator's opinion contraindicates study participation. 25. Has clinically significant abnormality at Screening or Baseline (Day
  12. 1) on 12-lead ECG, including a QT interval calculated using Fridericia's correction (
  13. QTcF) interval >450 milliseconds (
  14. msec) for males and 470 msec for females. 26. Is pregnant, planning to become pregnant during the study, or lactating. Has a positive serum and urine pregnancy test at Screening Visit, or a positive urine pregnancy test at Baseline (Day 1). 27. Has a positive urine drug screen for a nonprescribed drug prohibited by the protocol at Screening. 28. Has known alcohol or other substance abuse in the investigator's opinion. 29. Has participated in a previous clinical study with X0002. 30. Has participated in any other clinical trial within the past 30 days or within 5 half-lives of the study drug prior to Screening, whichever is longer. 31. Is a participating investigator, sub-investigator, study coordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned. 32. Has any factor that, in the investigator's opinion, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol. 33. Is without access to telephone and/or ability to gain technology access.

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

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