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Osteoarthritis, KneePhase 2OKINADANCT02471118

Osteoarthritis of the Knee, Inflammation, and the Effect of Adalimumab (OKINADA)

A Phase 2 study testing Adalimumab 40 mg in people with Osteoarthritis, Knee, run by CARE ARTHRITIS LTD. at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of inflammation, whose pain persists despite… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Adalimumab 40 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
7 sitesCanada
Study dates
Mar 2015to Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 40 years of age
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing methods of birth control.
  • If female and of childbearing potential, serum pregnancy results must be negative at Screening
  • Has a diagnosis of Osteoarthritis (OA) of the index knee according to American College of Rheumatology (ACR) criteria, including radiological evidence of OA (Kellgren-Lawrence grades 2 or 3).
  • Subject has had knee pain for at least 1 month prior to the Screening Visit.
  • Subject has had knee pain that has persisted despite conventional treatment, defined as any one of the following medications taken for at least 1 month in the past:
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  • acetaminophen (2- 4 grams per day)
  • therapeutic dose range of an NSAID
  • acetaminophen/codeine combination (i.e. Tylenol No. 2, 3, 4) taken at least 3 times daily.
  • Has a pain score of ≥ 4 (0-10 NRS) in the index (more symptomatic) knee at Screening and Baseline.
  • If the subject is taking Analgesic/NSAIDs, then the Analgesic/NSAIDs has been stable for 14 days prior to the Baseline visit.
  • Has clinical evidence of a knee effusion in the index (more symptomatic) knee at Screening and Baseline.
  • Able and willing to self-administer SC injections or has available qualified person(s) to administer SC injections.
  • Has voluntarily signed and dated an approved informed consent form prior to any study-specific procedures.

Who cannot join

  • Has a history of an allergic reaction or significant sensitivity to constituents of adalimumab.
  • Has other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease.
  • Subject has a BMI over 40.
  • Planned/anticipated surgery of the index knee during the study period.
  • Already scheduled for any surgery during the time of the study or within 70 days after the end of treatment.
  • Prior arthroscopic or open surgery of the index knee within 12 months of Baseline.
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  • Has a history of cancer or lymphoproliferative disease other than: Successfully and completely treated cervical dysplasia, with no recurrence within the last five years, Basal or Squamous Cell Carcinoma that has been adequately treated or excised.
  • Has had prior treatment with intravenous (IV) immunoglobulin or any investigational agent within 30 days or 5 half-lives of the agent from Baseline, whichever is longer.
  • History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease (e.g. multiple sclerosis).
  • History of uncontrolled diabetes, unstable ischemic heart disease, active congestive heart failure, New York Heart Association (NHYA) III, IV, inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 12 weeks of Screening), or any other condition, which in the opinion of the investigator, would put the patient at risk by participating in the study.
  • Has concurrent local or systemic infection that would preclude the use of adalimumab.
  • Has had a persistent or severe infection(s) requiring hospitalization or treatment with IV antibiotics within 30 days, or oral antibiotics within 14 days, prior to Baseline.
  • History of active tuberculosis or listeriosis, or other infections suggestive of significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis or other systemic protozoal or fungal infections.
  • Has latent TB (positive purified protein derivative (PPD) skin test, two-step PPD when applicable, and chest X-ray indicative of TB) or has other risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment.
  • Will be excluded if the Chest x-ray is found to have changes indicative of old healed tuberculous lesion (e.g. calcified nodule, fibrotic scar, apical or basilar pleural thickening etc.).
  • Has a positive serology for Hepatitis B or Hepatitis C that indicates active infection.
  • Has a history of positive HIV status.
  • Currently taking or likely to begin anti-retroviral therapy at any time during the course of the study.
  • Female subject is pregnant or breast-feeding.
  • Has a history of clinically significant drug or alcohol abuse in the last year, prior to Screening.
  • Subject, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
  • Treatment-Related Exclusion Criteria
  • Subject has received intra-articular injections of steroid and/or hyaluronate compounds into the index knee within 12 weeks prior to Baseline.
  • Subjects using injectable corticosteroids for any medical condition (intra-articular/soft tissue injections are allowed, but not in the target knee).
  • Subjects using indomethacin or oral steroids.
  • Subjects taking glucosamine and/or chondroitin at screening must discontinue or remain on a stable dose, unmodified if at all possible for the entire duration of the study.
  • If treatment for osteoarthritis (NSAID) or osteoporosis (bisphosphonates, selective estrogen receptor modulators) is necessary, it will have to be continued, unmodified if at all possible for the entire duration of the study. If the subject does not wish to continue them during the study, they must be stopped 14 days prior to the Baseline visit.
  • Subjects who have used compounds containing non-approved agents for arthritis or agents claiming to possess disease/structure-modifying properties in the 14 days prior to the Baseline visit (see exception above).
  • Subjects who require acetaminophen at daily doses > 4000 mg (4 g) on a regular basis.
  • Subjects who are taking lithium carbonate, phenytoin or anticoagulants (with the exception of aspirin up to a maximum daily dose of 325 mg).
  • Subjects who use calcitonin.
  • Subjects who use immunosuppressive drugs. Subjects that are using methotrexate or hydroxychloroquine must withdraw treatment 1 month prior to baseline, to be eligible to enter the study.
  • Topical analgesics and NSAID's cannot be used on the target knee within the 48 hours before each study visit.
  • No new physical modalities of treatment can be introduced and subject must maintain normal activity during the study.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Division of Rheumatology, University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Western University

    London, Ontario, N6A 4V2

  • A.M.I.R.

    Montreal, Quebec, H4A 3T2

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 7W9

  • GRMO Inc.

    Québec, Quebec, G1B3M7

  • Polmed Research Inc.

    Saskatoon, Saskatchewan, S7K 0H6

  • CHUS Hotel-Dieu

    Sherbrooke, Quebec, J1H 2E8

Other trials in Canada

About this study

Official title: Osteoarthritis of the Knee, Inflammation, and the Effect of Adalimumab (OKINADA): A Randomized Placebo-controlled Trial

This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of inflammation, whose pain persists despite receiving maximum tolerated doses of conventional therapy.

Read the detailed description

This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of inflammation, whose pain persists despite receiving maximum tolerated doses of conventional therapy. A total of 100 subjects will be entered into the study.

Subjects will be randomized (1:1) at baseline to receive either adalimumab 40 mg every other week or placebo for 16 weeks. The study drug will be self-administered via subcutaneous injection. Efficacy will be assessed at week 16 while the safety of the study drug will be monitored throughout the study. At week 16 all subjects will begin to receive open label adalimumab 40 mg every other week.

Being tested
Adalimumab 40 mg, Placebo
Keywords
Inflammatory Type
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalimumab 40 mgDrug

    Also called Humira

    Adalimumab will be self-administered via subcutaneous (SC) injection

  • PlaceboDrug

    Placebo will be self-administered via subcutaneous (SC) injection

Study groups in NCT02471118
Study groupRoleWhat they receive
1st 50 subjects to Enter the StudyExperimentalAt Baseline, subjects will be randomized (1:1) to receive study drug (Adalimumab or placebo). The study drug will be provided as a subcutaneous injection (pre-filled syringe) either Adalimumab (ADA) 40 mg/0.8 mL,every other week (EOW) or matching placebo for Adalimumab every other week for 16 weeks. Efficacy will be assessed at Week 16 while the safety of the study drug will be monitored throughout the study. At Week 16 all subjects will begin to receive open label ADA 40 mg EOW and will continue to receive open label ADA up to Week 50. An End of Study visit will be done at Week 52. A Telephone Follow-up will be done at Week 62 to review Adverse Events and Concomitant Medications.
Receives: Drug: Adalimumab 40 mg; Drug: Placebo
2nd group of 50 subjectsExperimentalAt Baseline, subjects will be randomized (1:1) to receive either adalimumab 40 mg every other week or placebo for 16 weeks. All subjects will begin to receive open label adalimumab 40 mg every other week from week 16-week 30, with An End of Study visit at Week 32. A Telephone Follow-up will be done at Week 42 to review Adverse Events and Concomitant Medications.
Receives: Drug: Adalimumab 40 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint: the percentage of subjects achieving an Osteoarthritis Research Society International/Outcome Measures in Rheumatology Clinical trials (OARSI/OMERACT) response at Week 16

    The primary efficacy outcome measure will be the percentage of subjects achieving an OARSI/OMERACT response at Week 16.

    Measured: 16 weeks

Secondary outcomes (11)

  1. Secondary endpoint Knee Injury and Osteoarthritis Outcome (KOOS) composite pain score at 16 weeks.

    1. KOOS composite pain score at 16 weeks.

    Measured: 16 weeks

  2. Secondary endpoint KOOS composite pain 20/50 response rates

    1. KOOS composite pain 20/50 response rates, i.e., the percentages of subjects showing ≥ 20% and ≥ 50% improvements from baseline in KOOS composite pain scores in the index knee at 16 weeks.

    Measured: 16 weeks

  3. Secondary Endpoint KOOS activities of daily living score

    1. KOOS activities of daily living score at 16 weeks.

    Measured: 16 Weeks

  4. Secondary Endpoint KOOS symptoms score

    1. KOOS symptoms score at 16 weeks.

    Measured: 16 weeks

  5. Secondary Endpoint KOOS sport and recreation function score

    1. KOOS sport and recreation function score at 16 weeks.

    Measured: 16 weeks

  6. Secondary Endpoint KOOS knee-related quality of life score

    1. KOOS knee-related quality of life score at 16 weeks.

    Measured: 16 weeks

  7. Secondary Endpoint Patient global assessment of disease status score

    1. Patient global assessment of disease status score at 16 weeks.

    Measured: 16 weeks

  8. Secondary Endpoint Investigator global assessment of disease status score

    1. Investigator global assessment of disease status score at 16 weeks.

    Measured: 16 Weeks

  9. Secondary Endpoint Physical assessment of Target Joint

    1. Physical assessment of Target Joint at 16 weeks.

    Measured: 16 weeks

  10. Secondary Endpoint Expanded Target Joint Assessment score

    1. Expanded Target Joint Assessment score at 16 weeks.

    Measured: 16 weeks

  11. Secondary Endpoint Average weekly consumption of analgesic medications

    1. Average weekly consumption of analgesic medications over 16 weeks.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2021
  4. Study completionMar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02471118
Sponsor's protocol ID
IMM 11-0024
Acronym
OKINADA
Status last verified
Oct 2021
First submitted
24 Feb 2015
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
No

Publications

  • 1. National Advisory Council on Aging and Public Health Agency of Canada, Division of Aging and Seniors. Musculoskeletal disorders such as arthritis and osteoporosis [Online]. Available at http://www.naca-ccnta.ca/vignette/vig69_e.htm#69. 2. Malemud CJ. Cytokines as therapeutic targets for osteoarthritis, BioDrugs 2004;18:23- 35. 3. Abramson SB, Yazici Y. Biologics in development for rheumatoid arthritis: Relevance to osteoarthritis. 4. Pelletier JP, Martel-Pelletier J, Abramson SB.Osteoarthritis, an inflammatory disease: potential implication for the selection of new therapeutic targets. Arthritis Rheum. 2001;44:1237-1247. 5. Felson DT, McLaughlin S, Goggins J, LaValley MP, Gale ME, Totterman S, Li W, Hill C, Gale D: Bone marrow edema and its relation to progression of knee osteoarthritis. Ann Intern Med 2003, 139:330-336. 6. Hunter DJ, Zhang Y, Niu J, Goggins J, Amin S, LaValley MP, Guermazi A, Genant H, Gale D, Felson DT: Increase in bone marrow lesions associated with cartilage loss: a longitudinal magnetic resonance imaging study of knee osteoarthritis. Arthritis Rheum 2006, 54:1529-1535. 7. Kornaat PR, Kloppenburg M, Sharma R, Botha-Scheepers SA, Le Graverand MP, Coene LN, Bloem JL, Watt I: Bone marrow edema-like lesions change in volume in the majority of patients with osteoarthritis; associations with clinical features. Eur Radiol 2007, 17:3073-3078. More references available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adalimumab 40 mg in people with Osteoarthritis, Knee, run by CARE ARTHRITIS LTD. at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint: the percentage of subjects achieving an Osteoarthritis Research Society International/Outcome Measures in Rheumatology Clinical trials (OARSI/OMERACT) response at Week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02471118, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.

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