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A Study Evaluating the Safety and Efficacy of a Second Course of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837900
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
OrthoTrophix, Inc

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of a second course of TPX-100 administered by intra-articular injection to subjects with osteoarthritis of the knee who participated in study TPX-100-1.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: TPX-100 200 mg 4 times weekly for 4 weeks Phase 2

Detailed Description:
Recruit up to 70 subjects whom participated in protocol TPX-100-1. The opposing knee that was treated will be getting 200mg in 4 weekly injections. The knee that was treated in TPX-100-1 will get randomized to either 200mg dose or a placebo lookalike. The investigators will follow these subjects for 6 months. Two MRIs of bi-lateral knees will be assessed. Also collection of ADA samples at 4 time points through the 6 month period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Safety and Efficacy of a Second Course of Intra-articular Injections of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Previous LT TX knee and right placebo
Previous left treated knee will have placebo treatment in this protocol.
 Drug: TPX-100 200 mg 4 times weekly for 4 weeks
Ea. subject will received active TPX-100 200mg in the Left knee
Other Name: TPX-100 100mg Left

Drug: TPX-100 200 mg 4 times weekly for 4 weeks
TPX-100 100mg Right
Other Name: TPX-100 100mg Left
Placebo Comparator: Previous RT TX knee and left placebo
Previous right treated knee will have placebo treatment in this protocol.
 Drug: TPX-100 200 mg 4 times weekly for 4 weeks
Ea. subject will received active TPX-100 200mg in the Left knee
Other Name: TPX-100 100mg Left

Drug: TPX-100 200 mg 4 times weekly for 4 weeks
TPX-100 100mg Right
Other Name: TPX-100 100mg Left
Active Comparator: Both TX with Active
Both knees with receive Active
 Drug: TPX-100 200 mg 4 times weekly for 4 weeks
Ea. subject will received active TPX-100 200mg in the Left knee
Other Name: TPX-100 100mg Left

Drug: TPX-100 200 mg 4 times weekly for 4 weeks
TPX-100 100mg Right
Other Name: TPX-100 100mg Left


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. evaluate the safety, tolerability, and preliminary efficacy of a second course of TPX-100 who participated in study TPX-100-1 [ Time Frame: Follow subjects for 6 months ]
    Safety, Tolerability and primary efficacy


Secondary Outcome Measures :
  1. Change in patellar cartilage thickness in each knee as measured on standardized MRI from baseline to 6 months. [ Time Frame: Follow subjects for 6 months ]
    Longitudinal changes in Patellar compartment cartilage thickness/thinness


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previous enrollment in study TPX-100-1

    • Cruciate and collateral ligament stability as defined by clinical examination
  2. Able to read, understand, sign and date the subject informed consent
  3. Willingness to use only acetaminophen as the primary analgesic (pain-relieving) study medication during the injection period and through study day 30. The maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg per day).
  4. Willingness to use only hydrocodone or hydrocodone/acetaminophen (e.g. Norco) for breakthrough pain through study day 30.
  5. Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen, naproxen through study day 30.
  6. Female subjects of child bearing potential who are sexually active (non-abstinent) must agree to and comply with using 2 highly effective methods of birth control (oral contraceptive, implant, injectable or indwelling intrauterine device, condom with spermicide, or sexual abstinence) while participating in the study.

Exclusion Criteria:

  1. "Possibly, probably or definitely" drug-related SAEs in TPX-100-1; severe or ongoing "possibly, probably or definitely" related AEs in TPX-100-1.
  2. Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
  3. Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
  4. Joint replacement or any other knee surgery planned in the next 12 months
  5. History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis

  6. Knee effusion > 2+ on the following clinical scale:

    • Zero = No wave produced on downstroke
    • Trace = Small wave on medial side with downstroke
    • 1+ = Larger bulge on medial side with downstroke
    • 2+ = Effusion spontaneously returns to medial side after upstroke (no downstroke necessary)
    • 3+ = So much fluid that it is not possible to move the effusion out of the medial aspect of the knee screening
  7. Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before screening
  8. Last intra-articular knee injection of corticosteroids < 2 months before screening
  9. Use of any steroids (except inhaled corticosteroids for respiratory problems) during the previous month before screening
  10. Known hypersensitivity to TPX-100
  11. Known hypersensitivity to acetaminophen or hydrocodone
  12. History of arthroscopy in either knee in the last 3 months before screening
  13. History of septic arthritis, gout or pseudo-gout, of either knee in previous year before screening
  14. Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
  15. Patellar chondrocalcinosis on X-Ray
  16. Skin problem, rash or hypersensitivity, affecting either knee at the injection site
  17. Bleeding problem, platelet or coagulation deficiency contraindicating, in the doctor's opinion, intra-articular injection
  18. Active systemic infection
  19. Current treatment or treatment within the previous 2 years prior to the Screening Visit for any malignancy except basal cell or squamous cell carcinoma of the skin, unless with specific written permission is provided by the Sponsor's medical monitor
  20. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
  21. Participation in other clinical osteoarthritis drug studies, with the exception of TPX-100-1, within one year prior to screening
  22. Currently taking Paclitaxel (mitotic inhibitor), natalizumab (anti-integrin monoclonal antibody), or any other anti-integrin treatment.
  23. History of significant liver disease or consumption of more than 3 alcoholic drinks a day. (Definition of one alcoholic drink: 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor such as gin, rum, vodka, or whiskey).
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: OrthoTrophix, Inc
ClinicalTrials.gov Identifier: NCT02837900    
Other Study ID Numbers: TPX-100-2
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases