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Rheumatoid ArthritisPhase 2NCT01561313

Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.

A Phase 2 study testing Adalimumab in people with Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 6 sites in 2 countries.

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 study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
6 sitesin 2 countries
Study dates
Mar 2012to Nov 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Male or female subject age 18 years or older, who requires Humira 40 mg SC every other week (eow) or every week (ew) for the treatment of rheumatoid arthritis, in accordance with the local Humira label.
  • Subject must be a current, on-label user of Humira who rates his/her average Humira injection site related pain as at least 3 cm on a pain Visual Analogue Scale and has had at least 6 consecutive doses of Humira prior to Screening, or a biologic naïve subject who requires initiation of on-label treatment with Humira.
  • Subject has diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised ACR classification criteria or the ACR/EULAR 2010 criteria,
  • Female subjects are either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy), or are practicing at least one method of birth control throughout the study and for at least 70 days after the last dose of study drug.
  • All female subjects of childbearing potential must have a negative test for pregnancy on a serum sample at Screening and prior to study drug dosing on a urine sample obtained at Visit 1.

Who cannot join

  • Subject has been treated with any investigational drug of a chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Visit 1.
  • Any infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Visit 1 or oral anti-infectives within 14 days prior to Visit 1.
  • Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
  • Known hypersensitivity to adalimumab or its excipients.
  • History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Belgium3 sites

  • Site Reference ID/Investigator# 63357

    Genk, 3600

  • Site Reference ID/Investigator# 63359

    Ghent, 9000

  • Site Reference ID/Investigator# 63360

    Ghent, 9000

Other trials in Belgium

Czechia3 sites

  • Site Reference ID/Investigator# 63363

    Brno, 63800

  • Site Reference ID/Investigator# 63362

    Prague, 128 50

  • Site Reference ID/Investigator# 63361

    Uherské Hradiště, 686 01

Other trials in Czechia

About this study

Official title: A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis.

This study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The study is being conducted in two countries, Belgium (3 sites) and the Czech Republic (3 sites).

Read the detailed description

64 participants were randomized, 63 received at least one dose of the study drug, and 62 participants were analyzed for injection site-related pain. 63 participants were analyzed for other safety analyses. Two participants, who were randomized to the Current formulation adalimumab/New formulation of adalimumab arm of the study were excluded from the analysis of injection site-related pain. One participant received one dose of study drug and discontinued because of an adverse event, while the other discontinued before receiving any study drug.

Being tested
Adalimumab
Keywords
On label Humira users, Pain, Rheumatoid Arthritis,
Medical subject headings
Arthritis, Rheumatoid, Pain

What participants receive

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

  • AdalimumabBiological

    Also called Humira, ABT-D2E7

    Subcutaneously 40 mg every other week (EOW) or every week (EW) (as dosing requires)

Study groups in NCT01561313
Study groupRoleWhat they receive
Current formulation adalimumabActive comparatorOne dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
Receives: Biological: Adalimumab
New formulation of adalimumabExperimentalOne dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Receives: Biological: Adalimumab

What is being measured

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

  1. Mean Injection Site Pain on a Visual Analogue Scale (VAS)

    The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.

    Measured: Immediately after injection

Secondary outcomes (6)

  1. Mean Injection Site Pain on a Visual Analogue Scale (VAS)

    The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection, with 0 representing no pain and 10 representing the worst possible pain.

    Measured: 15 minutes post injection

  2. Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale

    Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.

    Measured: 10 minutes and 30 minutes after injection

  3. Percentage of Participants With no Erythema in the Draize Scale

    Erythema (redness) was assessed.

    Measured: 10 minutes and 30 minutes after injection

  4. Percentage of Participants With no Edema in the Draize Scale

    Edema (swelling) was assessed.

    Measured: 10 minutes and 30 minutes after injection

  5. Percentage of Participants With no Pruritus in the Draize Scale

    Pruritus (itching) was assessed.

    Measured: 10 minutes and 30 minutes after injection

  6. Number of Participants With Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.

    Measured: Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious Adverse Events were collected from the time the participant signed the informed consent.

Timeline

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

  1. First posted23 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionNov 2012
  4. Study completionNov 2012

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
Single blind
Who is masked
Participant
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01561313
Sponsor's protocol ID
M12-783
Other IDs
2011-002275-41
Status last verified
Jan 2014
First submitted
21 Mar 2012
Last updated
20 Feb 2014
Data monitoring committee
No

Publications

  • Nash P, Vanhoof J, Hall S, Arulmani U, Tarzynski-Potempa R, Unnebrink K, Payne AN, Cividino A. Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2016 Dec;3(2):257-270. doi: 10.1007/s40744-016-0041-3. Epub 2016 Aug 18.

    PubMed 27747583

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adalimumab in people with Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 6 sites in 2 countries.

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 5 inclusion and 5 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 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Belgium, Czechia. 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?

Yes. Results are posted in the registry (first posted 20 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Injection Site Pain on a Visual Analogue Scale (VAS) (time frame: Immediately after injection). 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 NCT01561313, 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 20 Feb 2014.

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