Have Knee Pain?

Diagnosed with OSTEOARTHRITIS (OA) of the knee?

You may be eligible to participate in a clinical trial.

For full study information and to find out if there is a study site near you, please visit www.clinicaltrials.gov Study for No. NCT03281837. The study site personnel will inform you if you qualify to participate.

Why should I participate?

It is anticipated that this study treatment will provide relief of pain due to OA of the knee, but this benefit is not guaranteed.

This trial will gather more information about an approved treatment in patients who are diagnosed with pain due to OA of the knee.

This trial will assess the safety and performance of HYMOVIS® combined with a physical exercise program as compared to physical exercise alone for reducing pain.

You will be randomized to one of these treatment options. HYMOVIS® treatment consists of two weekly injections into the knee joint to relieve knee pain caused by knee OA.

How does the clinical trial work?

If you decide to participate and are eligible, you will be asked to complete:

  • Screening procedures
  • X-Ray & health assessments
  • Report medication use & pain levels
  • Between 5-7 clinic visits

You will be compensated for incidental expenses to cover out of pocket and travel expenses for follow up visits.

Hymovis is intended for those who do not get adequate pain relief from simple pain relievers like acetaminophen or from exercise and physical therapy. Voluntary participation will last approximately 6-9 months, with multiple clinic visits during this time. The physical exercise program arm will have the option later in the study to receive HYMOVIS®.

You may be eligible if you are:

  • Aged 21-60 years
  • Physically active
  • Have persistent knee pain lasting at least 3 months

But, you may not be eligible if you:

  • Had surgery to either of your knees in the last year
  • Had total knee joint replacement
  • Participated in a clinical drug or device study in the last 90 days.

What are the benefits and risks?

With any clinical trial, there are potential risks and benefits. The study personnel will inform you of these benefits and risks. Side effects most commonly seen after injection into the knee joint are knee pain, discomfort, swelling, stiffness, and itching at the injection site. These reactions are generally mild and do not last long.

Before receiving HYMOVIS®, tell your doctor if you are allergic to hyaluronan products, have an allergy to gram positive bacterial proteins or have an infection/skin disease in the area of the injection site.

HYMOVIS® is not approved for relieving pain in other joints besides the knee, for injection with other substances in your knee joint, or for children (<21 years of age). HYMOVIS® has not been tested in pregnant or nursing women. The effectiveness of repeat treatment cycles of HYMOVIS® has not been established.

Rx Only. Please see full Prescribing Information including indications, contraindications, adverse events, warnings, precautions, and side effects.

Important Safety Information

HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).

HYMOVIS® is contraindicated in patients with known hypersensitivity (allergy) to hyaluronate preparations or gram-positive bacterial proteins. Do not administer HYMOVIS® to patients with infections or skin diseases in the area of the injection site or joint.

The safety and effectiveness of the use of HYMOVIS® have not been tested in pregnant women, nursing mothers, or children. The safety and effectiveness of the use of HYMOVIS® in joints other than the knee, or for use concomitantly with other intra-articular (IA) injections, have not been established. The effectiveness of repeat treatment cycles of HYMOVIS® has not been established.

Arthralgia, transient pain, or swelling may occur after the IA injection. The incidence of arthralgia in the clinical study for HYMOVIS® was equivalent to the control group. No serious adverse events or pseudoseptic reactions were reported. Transient increases in inflammation following any IA hyaluronan injection have been reported in some patients with inflammatory joint conditions.

Strict aseptic technique should be used by licensed medical professionals trained to deliver agents into the knee joint. Joint effusion should be removed prior to injection of HYMOVIS®. Do not use disinfectants containing quaternary ammonium salts for skin preparation as hyaluronan can precipitate in their presence.

Patients should avoid strenuous or prolonged (eg, more than one hour) physical activities within 48 hours following the IA injection.

Please see Prescribing Information.

Rx Only

HYMOVIS and HYADD 4 are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. HYMOVIS® is manufactured by Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2017 Fidia Pharma USA Inc, Florham Park, NJ 07932