Phase 3
Completed N=867
CLARITY Extension Study
Source: ClinicalTrials.gov NCT00641537 ↗Enrolled (actual)
867
Serious AEs
11.5%
Results posted
Dec 2013
Primary outcomePrimary: Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity — 0.0; 0.0; 2.7; 3.2 percentage of participants
Summary
The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity |
0.0; 0.0; 2.7; 3.2; 0.4; 0.0 | — |
| PRIMARY Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120 |
0.3; 0.3; 0.0; 0.0; -0.6; -7.7 | — |
| PRIMARY Safety Population: Mean Change From Baseline in Hemoglobin at Week 120 |
0.2; 0.2; -0.1; 0.1; -0.1 | — |
| PRIMARY Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120 |
0.7; -1.1; 2.2; 0.7; 0.5; 2.2 | — |
| PRIMARY Safety Population: Mean Change From Baseline in Bilirubin at Week 120 |
0.1; 0.0; -0.8; -0.8; -0.4 | — |
| PRIMARY Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
74; 71; 149; 149; 194; 16 | — |
| PRIMARY SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
16; 13; 18; 2; 1; 3 | — |
| PRIMARY Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies |
6; 4; 6; 13; 11; 8 | — |
| PRIMARY SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies |
0; 1; 1; 0; 1; 2 | — |
| PRIMARY Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity |
NA; NA; 14; 8; 362; NA | — |
| PRIMARY Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity |
22.0; 31.5; 212.0; 168.0; 111.3; 99.0 | — |
| PRIMARY Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity |
41.0; 34.9; 256.7; 241.8; 160.2; 99.0 | — |
| PRIMARY Safety Population: Median Time to Nadir of Absolute Lymphocyte Count |
162.0; 93.0; 365.0; 162.0; 380.0 | — |
| PRIMARY Safety Population: Mean Time to Nadir of Absolute Lymphocyte Count |
292.0; 193.6; 276.7; 241.1; 362.9 | — |
| PRIMARY Safety Population: Mean Time to Recovery From Nadir of Absolute Lymphocyte Count to Normal Value |
79.0; 72.7; 237.5; 245.3; 187.8 | — |
| PRIMARY Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline |
7.0; 7.4; 4.5; 4.3; 0.7; 16.9 | — |
Eligibility Criteria
Inclusion Criteria
- Randomized in Trial 25643 and satisfied one of the following:
- Completed randomized treatment course and scheduled visits for the full 96 weeks; or
- Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
- Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
- Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
- Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
- No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray
- All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:
- Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
- Leukocytes (total white blood cell) = 4.1 to 12.3*10^3 per microliter
- Absolute lymphocyte count (ALC) = 1.02 to 3.36*10^3 per microliter
- Absolute neutrophil count (ANC) = 2.03 to 8.36*10^3 per microliter
- Platelet count = 140 to 450*10^3 per microliter
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion Criteria
- Participants who were not enrolled in Trial 25643
- Participant has moderate to severe renal impairment
- Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
- Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
- Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1
Data sourced from ClinicalTrials.gov (NCT00641537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.